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If you have any questions, please contact the JHM eIRB at email@example.com or 410-955-3008.
Update November 17, 2016
As part of scheduled updates, the following changes will be made in eIRB2:
1 - General Information & 2 – Study Team Compliance Training
- Study team members will be listed in alphabetical order by last name in Section 1 (General Information) and Section 2 (Study Team Compliance Training) of the eIRB application.
7 – Clinical Trial Information
- Language revisions were made for consistency with the updated JHM IRB Organization Policy on Registration of Clinical Trials.
13 – Recruitment Information
- Q4 appears if “Prior Hopkins/Affiliates study participants” is checked in Q1. If multiple boxes are checked in Q1, it is not easy to determine which checkbox triggers Q4 to be shown. As a result, the investigator may include erroneous information in Q4. Additional language has been added to help clarify what is being asked:
- Current Question: Please list the Hopkins/Affiliates study number(s) and associated Principal Investigator(s):
- Revised Question: Please list the Hopkins/Affiliates IRB application number(s) and the name of the Principal Investigator(s) for each study that will be used to recruit prior participants for this study.
15 – Written Consent
- Q2 (How many participants will be consented (or enrolled with a waiver of consent) will now allow an answer of "0".
24 – IBC/RAC
- Changes have been made in Section 24 - IBC/RAC of the eIRB application, which resulted from a meeting with Steve Dahl, Director of Biosafety. Changes include revisions to language and hide/show rules.
34 – SKCCC CRO
- Q8 and Q9:
- Current Q8: Will you use the services of the Weinberg pharmacy?
- Revised Q8: Will you use the services of the Weinberg or Bayview Investigational pharmacy?
- Current Q9: Will a pharmacy budget be developed? (If ‘yes’ you are agreeing to be billed for pharmacy fees)
- Revised Q9: Will a Weinberg pharmacy budget be developed? (If ‘yes’ you are agreeing to be billed for pharmacy fees).
Continuing Review Application
4 - Study Population
- Current Q2: If you are using CRMS, upload the CRMS Continuing Review Enrollment Summary Report below and you do not need to complete the rest of this screen. Please see the help section to learn how to obtain this summary report; the IRB does not want patient-specific information.
Revised Q2: If you are using CRMS, upload the CRMS Continuing Review Enrollment Summary Report below and you do not need to complete item 3 below the rest of this screen. Please see the help section to learn how to obtain this summary report; the IRB does not want patient-specific information.