Web notes  

 
HUMAN SUBJECTS RESEARCH

NOVEMBER 2019

Changes in HSR Recertification
Go online for updated information on required training for Human Subjects Research Recertification courses.

Research Billing Buzz eNewsletter - October 2019
Read the October issue of the Clinical Research Billing Compliance new eNewsletter created to help understand billing and importance of Epic and CRMS. Get on the mailing list for future issues.

Update on Insurance and Research Participant Financial Responsibility Information Sheet: Signature No Longer Required
Necesary updates detailed onilne.

Change in JHM IRB Review Fees for Commercially-Funded Studies
Beginning August 1, additional fees will be collected for IRB review of commercially-funded studies with financial support in excess of $10,000.

Data and Safety Monitoring Board Training Manual Now Available
The CTSA Collaborative DSMB Workgroup announces online Training Manual to provide guidance, training and resources in DSMB practices for investigator-initiated research studies.

Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

Fee Schedule Adjustment for Hospital Services Charged to Clinical Trial Budgets
Go online to see new, approved rate reduction percentages effective for statements generated after March 1, 2018.

Changes to NIH-funded Human Subjects Research

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
Archived Articles
 
OCTOBER 2019

Henrietta Lacks Memorial Lecture - 10th Anniversary!
Hear keynote speaker Dr. Griffin Rodgers, director of the National Institutes of Diabetes and Digestive and Kidney Diseases, during the 10th anniversary celebrating the legacy of Mrs. Henrietta Lacks, Saturday, October 5.

Training Opportunity: Single IRB Requirement for Cooperative Research
Courses outlining sIRB reuirements and describing the process for requesting reliance on JHM or external IRB will be held in September and October. Go online for dates and times. Attendance will count toward PI recertification.

Research Billing Buzz eNewsletter - July 2019
Read the July issue of the Clinical Research Billing Compliance new eNewsletter created to help understand billing and importance of Epic and CRMS. Get on the mailing list for future issues.

Update on Insurance and Research Participant Financial Responsibility Information Sheet: Signature No Longer Required
Necesary updates detailed onilne.

Change in JHM IRB Review Fees for Commercially-Funded Studies
Beginning August 1, additional fees will be collected for IRB review of commercially-funded studies with financial support in excess of $10,000.

Data and Safety Monitoring Board Training Manual Now Available
The CTSA Collaborative DSMB Workgroup announces online Training Manual to provide guidance, training and resources in DSMB practices for investigator-initiated research studies.

Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

Fee Schedule Adjustment for Hospital Services Charged to Clinical Trial Budgets
Go online to see new, approved rate reduction percentages effective for statements generated after March 1, 2018.

Changes to NIH-funded Human Subjects Research

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
SEPTEMBER 2019

Henrietta Lacks Memorial Lecture - 10th Anniversary!
Hear keynote speaker Dr. Griffin Rodgers, director of the National Institutes of Diabetes and Digestive and Kidney Diseases, during the 10th anniversary celebrating the legacy of Mrs. Henrietta Lacks, Saturday, October 5.

Training Opportunity: Single IRB Requirement for Cooperative Research
Courses outlining sIRB reuirements and describing the process for requesting reliance on JHM or external IRB will be held in September and October. Go online for dates and times. Attendance will count toward PI recertification.

Research Billing Buzz eNewsletter - July 2019
Read the July issue of the Clinical Research Billing Compliance new eNewsletter created to help understand billing and importance of Epic and CRMS. Get on the mailing list for future issues.

Update on Insurance and Research Participant Financial Responsibility Information Sheet: Signature No Longer Required
Necesary updates detailed onilne.

Change in JHM IRB Review Fees for Commercially-Funded Studies
Beginning August 1, additional fees will be collected for IRB review of commercially-funded studies with financial support in excess of $10,000.

Data and Safety Monitoring Board Training Manual Now Available
The CTSA Collaborative DSMB Workgroup announces online Training Manual to provide guidance, training and resources in DSMB practices for investigator-initiated research studies.

Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

Fee Schedule Adjustment for Hospital Services Charged to Clinical Trial Budgets
Go online to see new, approved rate reduction percentages effective for statements generated after March 1, 2018.

Changes to NIH-funded Human Subjects Research

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
AUGUST 2019

Update on Insurance and Research Participant Financial Responsibility Information Sheet: Signature No Longer Required
Necesary updates detailed onilne.

Research Billing Buzz eNewsletter - July 2019
Read the July issue of the Clinical Research Billing Compliance new eNewsletter created to help understand billing and importance of Epic and CRMS. Get on the mailing list for future issues.

Third Thursdays with the ICTR Lecture Series
Designed to directly aid clinical research study team members, this month's lecture is titled "Meeting the Demand for Transparency through Clinicaltrials.gov Compliance" and will be held on June 20.

Clinical Research Annual Reports
Overview of year of clinical research detailed including research participant satisfaction and program growth avaialable online.

Change in JHM IRB Review Fees for Commercially-Funded Studies
Beginning August 1, additional fees will be collected for IRB review of commercially-funded studies with financial support in excess of $10,000.

Data and Safety Monitoring Board Training Manual Now Available
The CTSA Collaborative DSMB Workgroup announces online Training Manual to provide guidance, training and resources in DSMB practices for investigator-initiated research studies.

Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

Fee Schedule Adjustment for Hospital Services Charged to Clinical Trial Budgets
Go online to see new, approved rate reduction percentages effective for statements generated after March 1, 2018.

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
JULY 2019

Update on Insurance and Research Participant Financial Responsibility Information Sheet: Signature No Longer Required
Necesary updates detailed onilne.

Research Billing Buzz eNewsletter - June 2019
Read the June issue of the Clinical Research Billing Compliance new eNewsletter created to help understand billing and importance of Epic and CRMS. Get on the mailing list for future issues.

Third Thursdays with the ICTR Lecture Series
Designed to directly aid clinical research study team members, this month's lecture is titled "Meeting the Demand for Transparency through Clinicaltrials.gov Compliance" and will be held on June 20.

Clinical Research Annual Reports
Overview of year of clinical research detailed including research participant satisfaction and program growth avaialable online.

Change in JHM IRB Review Fees for Commercially-Funded Studies
Beginning August 1, additional fees will be collected for IRB review of commercially-funded studies with financial support in excess of $10,000.

Data and Safety Monitoring Board Training Manual Now Available
The CTSA Collaborative DSMB Workgroup announces online Training Manual to provide guidance, training and resources in DSMB practices for investigator-initiated research studies.

Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

Fee Schedule Adjustment for Hospital Services Charged to Clinical Trial Budgets
Go online to see new, approved rate reduction percentages effective for statements generated after March 1, 2018.

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
JUNE 2019

Research Billing Buzz eNewsletter - May 2019
Read the May issue of the Clinical Research Billing Compliance new eNewsletter created to help understand billing and importance of Epic and CRMS. Get on the mailing list for future issues.

Third Thursdays with the ICTR Lecture Series
Designed to directly aid clinical research study team members, this month's lecture is titled "Meeting the Demand for Transparency through Clinicaltrials.gov Compliance" and will be held on June 20.

Clinical Research Annual Reports
Overview of year of clinical research detailed including research participant satisfaction and program growth avaialable online.

Change in JHM IRB Review Fees for Commercially-Funded Studies
Beginning August 1, additional fees will be collected for IRB review of commercially-funded studies with financial support in excess of $10,000.

Data and Safety Monitoring Board Training Manual Now Available
The CTSA Collaborative DSMB Workgroup announces online Training Manual to provide guidance, training and resources in DSMB practices for investigator-initiated research studies.

Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

Fee Schedule Adjustment for Hospital Services Charged to Clinical Trial Budgets
Go online to see new, approved rate reduction percentages effective for statements generated after March 1, 2018.

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
MAY 2019

New! Research Billing Buzz eNewsletter
Read the first issue of the Clinical Research Billing Compliance new eNewsletter created to help understand billing and importance of Epic and CRMS. Get on the mailing list for future issues.

Third Thursdays with the ICTR Lecture Series
Designed to directly aid clinical research study team members, this month's lecture is titled "Epic Showcase, What Epic can do for your Researcht" and will be held on April 18.

Institutional Review Board (IRB) Open House
The Johns Hopkins Office of Human Subjects Research is holding its 4th Annual Meet and Greet Open House on May 17 in Reed Hall. Go online to register for workshops.

Johns Hopkins inHealth Precision Medicine Symposium
Register now for the May 30 symposium titled "Precision Medicine and the transformation of healthcare: advancing health using novel measurement, analysis, and communication."

Clinical Research Annual Reports
Overview of year of clinical research detailed including research participant satisfaction and program growth avaialable online.

Change in JHM IRB Review Fees for Commercially-Funded Studies
Beginning August 1, additional fees will be collected for IRB review of commercially-funded studies with financial support in excess of $10,000.

Data and Safety Monitoring Board Training Manual Now Available
The CTSA Collaborative DSMB Workgroup announces online Training Manual to provide guidance, training and resources in DSMB practices for investigator-initiated research studies.

Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

Fee Schedule Adjustment for Hospital Services Charged to Clinical Trial Budgets
Go online to see new, approved rate reduction percentages effective for statements generated after March 1, 2018.

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
APRIL 2019

Third Thursdays with the ICTR Lecture Series
Designed to directly aid clinical research study team members, this month's lecture is titled "Epic Showcase, What Epic can do for your Research" and will be held on April 18.

Johns Hopkins inHealth Precision Medicine Symposium
Register now for the May 30 symposium titled "Precision Medicine and the transformation of healthcare: advancing health using novel measurement, analysis, and communication."

Clinical Research Annual Reports
Overview of year of clinical research detailed including research participant satisfaction and program growth avaialable online.

Change in JHM IRB Review Fees for Commercially-Funded Studies
Beginning August 1, additional fees will be collected for IRB review of commercially-funded studies with financial support in excess of $10,000.

Data and Safety Monitoring Board Training Manual Now Available
The CTSA Collaborative DSMB Workgroup announces online Training Manual to provide guidance, training and resources in DSMB practices for investigator-initiated research studies.

Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

Fee Schedule Adjustment for Hospital Services Charged to Clinical Trial Budgets
Go online to see new, approved rate reduction percentages effective for statements generated after March 1, 2018.

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
MARCH 2019

Third Thursdays with the ICTR Lecture Series
Designed to directly aid clinical research study team members, this month's lecture is titled "MyPath Story Booth Project" and will be held on March 21.

Clinical Research Annual Reports
Overview of year of clinical research detailed including research participant satisfaction and program growth avaialable online.

Change in JHM IRB Review Fees for Commercially-Funded Studies
Beginning August 1, additional fees will be collected for IRB review of commercially-funded studies with financial support in excess of $10,000.

Data and Safety Monitoring Board Training Manual Now Available
The CTSA Collaborative DSMB Workgroup announces online Training Manual to provide guidance, training and resources in DSMB practices for investigator-initiated research studies.

Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
FEBRUARY 2019

Third Thursdays with the ICTR Lecture Series
Designed to directly aid clinical research study team members, this month's lecture is titled "Resources for Data Management" and will be held on February 21.

Clinical Research Annual Reports
Overview of year of clinical research detailed including research participant satisfaction and program growth avaialable online.

Change in JHM IRB Review Fees for Commercially-Funded Studies
Beginning August 1, additional fees will be collected for IRB review of commercially-funded studies with financial support in excess of $10,000.

Data and Safety Monitoring Board Training Manual Now Available
The CTSA Collaborative DSMB Workgroup announces online Training Manual to provide guidance, training and resources in DSMB practices for investigator-initiated research studies.

Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
JANUARY 2019

Clinical Research Annual Reports
Overview of year of clinical research detailed including research participant satisfaction and program growth avaialable online.

Change in JHM IRB Review Fees for Commercially-Funded Studies
Beginning August 1, additional fees will be collected for IRB review of commercially-funded studies with financial support in excess of $10,000.

Data and Safety Monitoring Board Training Manual Now Available
The CTSA Collaborative DSMB Workgroup announces online Training Manual to provide guidance, training and resources in DSMB practices for investigator-initiated research studies.


Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

 

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
DECEMBER 2018

Clinical Research Annual Reports
Overview of year of clinical research detailed including research participant satisfaction and program growth avaialable online.

Change in JHM IRB Review Fees for Commercially-Funded Studies
Beginning August 1, additional fees will be collected for IRB review of commercially-funded studies with financial support in excess of $10,000.

Data and Safety Monitoring Board Training Manual Now Available
The CTSA Collaborative DSMB Workgroup announces online Training Manual to provide guidance, training and resources in DSMB practices for investigator-initiated research studies.


Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

 

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
NOVEMBER 2018

Trends in Clinical Research Program
The November 8 seminar on Blurring of the Boundaries Between Clinical Research and Clinical Practice features speaker Jonathan Moreno, PhD, University of Pennsylvania.

Clinical Research Annual Reports
Overview of year of clinical research detailed including research participant satisfaction and program growth avaialable online.

Change in JHM IRB Review Fees for Commercially-Funded Studies
Beginning August 1, additional fees will be collected for IRB review of commercially-funded studies with financial support in excess of $10,000.

Data and Safety Monitoring Board Training Manual Now Available
The CTSA Collaborative DSMB Workgroup announces online Training Manual to provide guidance, training and resources in DSMB practices for investigator-initiated research studies.


Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

 

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
OCTOBER 2018

Trends in Clinical Research Program
The November 8 seminar on Blurring of the Boundaries Between Clinical Research and Clinical Practice features speaker Jonathan Moreno, PhD, University of Pennsylvania.

Clinical Research Annual Reports
Overview of year of clinical research detailed including research participant satisfaction and program growth avaialable online.

Change in JHM IRB Review Fees for Commercially-Funded Studies
Beginning August 1, additional fees will be collected for IRB review of commercially-funded studies with financial support in excess of $10,000.

Data and Safety Monitoring Board Training Manual Now Available
The CTSA Collaborative DSMB Workgroup announces online Training Manual to provide guidance, training and resources in DSMB practices for investigator-initiated research studies.


Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

 

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
SEPTEMBER 2018

Clinical Research Annual Reports
Overview of year of clinical research detailed including research participant satisfaction and program growth avaialable online.

Change in JHM IRB Review Fees for Commercially-Funded Studies
Beginning August 1, additional fees will be collected for IRB review of commercially-funded studies with financial support in excess of $10,000.

Data and Safety Monitoring Board Training Manual Now Available
The CTSA Collaborative DSMB Workgroup announces online Training Manual to provide guidance, training and resources in DSMB practices for investigator-initiated research studies.


Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

 

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
AUGUST 2018

Change in JHM IRB Review Fees for Commercially-Funded Studies
Beginning August 1, additional fees will be collected for IRB review of commercially-funded studies with financial support in excess of $10,000.

Data and Safety Monitoring Board Training Manual Now Available
The CTSA Collaborative DSMB Workgroup announces online Training Manual to provide guidance, training and resources in DSMB practices for investigator-initiated research studies.


Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

 

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
JULY 2018

Data and Safety Monitoring Board Training Manual Now Available
The CTSA Collaborative DSMB Workgroup announces online Training Manual to provide guidance, training and resources in DSMB practices for investigator-initiated research studies.

2018 Johns Hopkins Clinical Research Scholars in Women's Health Awardees
Recipients receive research and mentoring resources, salary support, and career development activities to faculty members. Meet the winners.


Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

 

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
JUNE 2018

Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

 

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
MAY 2018

OHSR & IRB Meet and Greet Open House
Meet the JH research community, network and register for one or more information sessions on specific topics pertaining to research and the IRB submission process on May 11.

Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

 

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
APRIL 2018

Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research
Register online for the 90-minute training sessions held on the fourth Friday of each month.

 

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
MARCH 2018

Training Session: Understanding Changes to the Federal Policy on Protection of Human Subjects (the Common Rule)

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
FEBRUARY 2018

Training Session: Understanding Changes to the Federal Policy on Protection of Human Subjects (the Common Rule)

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
JANUARY 2018

Training Session: Understanding Changes to the Federal Policy on Protection of Human Subjects (the Common Rule)

Change in Federalwide Assurance [FWA] Numbers
Effective November 1, changes include closing existing numbers and streamlining others. Details online.

Changes to NIH-funded Human Subjects Research

New Fee Schedule for Commercially Funded Studies
Change in JHM IRB review fees for any commercially funded study with financial support in excess of $10,000, effective July 1.

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network
 
Archived Articles
 
DECEMBER 2017
Johns Hopkins Clinical Research Network
 
NOVEMBER 2017
Johns Hopkins Clinical Research Network
 
OCTOBER 2017

Johns Hopkins Clinical Research Network

 
SEPTEMBER 2017

Changes to NIH-funded Human Subjects Research

Training Sessions: Preparing for NIH's Single IRB Review Requirement

New Fee Schedule for Commercially Funded Studies
Change in JHM IRB review fees for any commercially funded study with financial support in excess of $10,000, effective July 1.

NIH Requirement for Single IRB (sIRB)
Effective September 25, NIH requires all grant applications for specific human subject research studies to include proposal for use of a single IRB ("sIRB") to review research.

JHM IRB Reliance Requests
Go online for process to submit reliance requests to JHM IRB.

Sharing Partnership for Innovative Research in Translation
SPIRIT, a partnership among seven universities including JHU, seeks to fund scientists researching varying health concerns, from creating tumor-destroying viruses to decreasing large numbers of mentally ill in the criminal justice system.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network

 
AUGUST 2017

Johns Hopkins Clinical Research Network

Archived articles:
 
JULY 2017

Johns Hopkins Clinical Research Network

JHM HSR Recertification Training
HSR recertification is required for new application submissions only and change in research submissions, and is required every three years
.

 
JUNE 2017

Johns Hopkins Clinical Research Network

JHM HSR Recertification Training
HSR recertification is required for new application submissions only and change in research submissions, and is required every three years
.

 
MAY 2017

Johns Hopkins Clinical Research Network

JHM HSR Recertification Training
HSR recertification is required for new application submissions only and change in research submissions, and is required every three years
.

 
APRIL 2017

Johns Hopkins Clinical Research Network

JHM HSR Recertification Training
HSR recertification is required for new application submissions only and change in research submissions, and is required every three years
.

 
MARCH 2017

Laboratory Methods for Translational Scientists
Free, all day course on March 3, is targeted to young clinical investigators requiring laboratory support for clinical research. Course covers laboratory technologies employed to characterize drugs and biologics in bodily fluids and tissues.

New Approaches to Metabolomics Research
Register online for March 14 symposium on Metabolomics, featuring keynote speakers, Charles Burant, MD, PhD University of Michigan Nutrition Obesity Research Center and Gary Siuzdak, PhD, director of the Scripps Center for Metabolomics.

Improving Long Term Outcomes Research
On March 14, Dale Needham, MD, PhD and research team present overview of the free resources for conducting clinical research, funded by his National Heart Lung and Blood Institute R24 national infrastructure grant.

Third Thursdays with the ICTR
Next in lecture series is Thursday, March 16, where speakers share research related news and showcase a resource and/or service that can aid clinical research team members. Register online for the next lecture with Nidhi Atri, M.D. and Anthony Keyes, MBA, PMP

Funding Opportunity: Nexus Award for Externships in Drug and Device Development
Designed for researchers interested in collaboration with colleagues outside of JH, award provides funds to investigators engaged in drugs, biologics, vaccines or device design. Applications due Apirl 3.

Johns Hopkins Institute for Clinical and Translational Research
Check out the many services and clinical resources for faculty and student investigators on the ICTR website.

Johns Hopkins Clinical Research Network

JHM HSR Recertification Training
HSR recertification is required for new application submissions only and change in research submissions, and is required every three years
.

 
FEBRUARY 2017

Johns Hopkins Clinical Research Network

JHM HSR Recertification Training
HSR recertification is required for new application submissions only and change in research submissions, and is required every three years
.

 
JANUARY 2017

Johns Hopkins Clinical Research Network

JHM HSR Recertification Training
HSR recertification is required for new application submissions only and change in research submissions, and is required every three years
.

 
DECEMBER 2016

Johns Hopkins Clinical Research Network

JHM HSR Recertification Training
HSR recertification is required for new application submissions only and change in research submissions, and is required every three years
.

 
NOVEMBER 2016

Johns Hopkins Clinical Research Network Seminar: The Changing Landscape in Multi-Center Clinical Research

Johns Hopkins Clinical Research Network

JHM HSR Recertification Training
HSR recertification is required for new application submissions only and change in research submissions, and is required every three years
.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
   
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