Top Ten eIRB Application Mistakes And what to know To Avoid Them

FUN FACTS!!!! Scheduling an eIRB application action can take up to 3-6 weeks depending on volume, time of year, staffing, and complexity of the research project. “Normal scheduling time” is 2-4 weeks from the final PI submission date. THE IRB MEETS WEEKLY WITH THE EXCEPTION OF THE WEEK BETWEEN CHRISTMAS AND NEWYEAR’S DAY.

Getting it right Common application processing errors can cost valuable research time. We want to help you to get it as right as possible the first time!

Fun facts!!!! 99% of new applications are returned for corrections and/or clarification at least once. 70% of all change in research applications are returned for corrections and/or clarification. Less than half continuing review applications, problem events, and termination reports are returned for corrections and/or clarification.

1. COMMON PRE-REVIEW MEETING APPLICATION ERRORS NOT UPLOADING DOCUMENTS TO THE CORRECT SECTION OF THE APPLICATION PROVIDING TRACKED CHANGE VERSIONS OF NEW DOCUMENTS INFORMATION INCONSISTENT BETWEEN PROTOCOL, CONSENT FORM, RECRUITMENT MATERIAL, AND EIRB APPLICATION NOT DISCLOSING CONFLICTS OF INTEREST TO THE OFFICE OF POLICY COORDINATION NOT REVIEWING AND ACCEPTING THE PRA

2. COMMON POST-MEETING REVIEW APPLICATION ERRORS NOT IDENTIFYING ADDITIONAL CHANGES BEING PROPOSED OUTSIDE OF WHAT THE BOARD REQUESTED PROVIDING CLEAN VERSIONS OF REVISED DOCUMENTS INSTEAD OF TRACKED VERSIONS MAKING ADDITIONAL APPLICATION CHANGES WHEN AN ACTION IS APPROVED WITH ADMINISTRATIVE CHANGES

3. Common Study team member errors MISSING HSR, COI, H&R, CRBO, AND/or RECERTIFICATION COMPLIANCE TRAINING CERTIFICATES/DATES NOT ADDING OR DELETING STUDY TEAM MEMBERS WHEN SUBMITTING STUDY TEAM CHANGE APPLICATIONS NOT NAMING THE STUDY TEAM MEMBERS WHO HAVE BEEN ADDED OR DELETED WITH A CHANGE REQUEST CHANGING THE PI AND BUT NOT DELETING THE PI AS A STUDY TEAM MEMBER NOT REVISING THE DRUG DATA SHEET, RECRUITMENT MATERIAL, CONSENT FORM, AND/OR MID-LEVEL PROVIDER LIST TO BE CONSISTENT WITH STUDY TEAM MEMBER LIST CHANGES RECONCILING THE STUDY TEAM MEMBER LIST ON INVESTIGATOR- INITIATED PROTOCOLS AND SPONSOR PROTOCOLS

4. COMMON DOCUMENT UPLOAD ERRORS USING THE “ADD” FUNCTION TO UPLOAD REVISED VERSIONS OF SUBMITTED DOCUMENTS ALL RECRUITMENT MATERIAL MUST CONTAIN THE FOLLOWING: PI NAME, DESIGNATION AS PI, EIRB APPLICATION NUMBER, AND THE TERM “RESEARCH STUDY” ALL EFORMA AND CONSENT FORM DOCUMENTS MUST CONTAIN THE FOLLOWING: PI NAME, EIRB APPLICATION NUMBER, AND CURRENT SUBMISSION DATE FOR SPONSORED PROTOCOL APPLICATIONS, THE SPONSOR’S CONSENT FORM IS REQUIRED FOR REVIEW CHECK THE IRB WEBSITE TO ENSURE THAT YOU’RE USING THE LATEST VERSION OF THE FORM YOU ARE SUBMITTING DELETING DOCUMENTS IN EIRB

5. COMMON CONSENT FORM ERRORS USING THE ADD FUNCTION TO UPLOAD REVISED VERSIONS OF PREVIOUSLY APPROVED CONSENT FORMS NOT USING THE LAST APPROVED VERSION OF THE CONSENT FORM TO MAKE PROPOSED CHANGES CONVERTING THE LAST APPROVED VERSION FROM THE .PDF FILE TO MAKE CHANGES NOT PROVIDING THE SPONSOR VERSION OF THE CONSENT FORM NOT USING THE LATEST TEMPLATE VERSION WHEN MAKING CHANGES AFTER LONG PERIODS OF TIME NOT INCLUDING OR REMOVING REQUIRED LANGUAGE (E.G., CONFLICT OF INTEREST, RADIATION, HIPAA 3)

6. COMMON DRUG SECTION APPLICATION ERRORS NOT LISTING THE DRUG AT THE CORRECT CLASSIFICATION/FDA DETERMINATION IN SECTION 21 FDA-APPROVED PRODUCTS – NOT LISTING ALL PROTOCOLIZED DRUGS AT QUESTION 9 NOT PROVIDING THE INVESTIGATOR BROCHURE AND/OR DRUG DATA SHEET IF THERE IS AN IND/IDE FOR THE STUDY, THE FDA COMPLETED A SCIENTIFIC REVIEW NOT PROVIDING FDA DOCUMENTATION (E.G., IND EXEMPT DETERMINATION, STUDY MAY PROCEED LETTERS, 510K LETTERS)

7. COMMON DEVICE SECTION APPLICATION ERRORS NOT LISTING ALL PROTOCOLIZED DEVICES NOT PROVIDING FDA DOCUMENTATION (E.G., IND EXEMPT DETERMINATION, STUDY MAY PROCEED LETTERS, 510K LETTERS) NOT PROVIDING CLINICAL ENGINEERING APPROVAL DOCUMENTS

8. COMMON APPLICATION SECTION ERRORS Section 1, Question 2 (when there is a COI) SECTION 6, QUESTION 7 SECTION 11, QUESTIONS 2, 4, AND 5 SECTION 12, QUESTION 1 AND 4 SECTION 13, QUESTION 1 SECTION 15, QUESTIONS 1, 2, 4, AND 9 SECTION 20, QUESTION 1 SECTION 23, QUESTION 3

9. COMMON CHANGE IN RESEARCH APPLICATION ERRORS NOT CHECKing THE APPROPRIATE BOXES TO INDICATE WHICH CHANGES ARE BEING PROPOSED UPLOADING APPLICATION DOCUMENTS TO CIR SECTION 1, QUESTION 3 ONLY NOT PROVIDING A SUFFICIENT EXPLANATION FOR THE CIR SUBMISSION NOT UPLOADING CLEAN VERSIONS OF REVISED DOCUMENTS NOT UPLOADING TRACKED CHANGE VERSIONS OF REVISED DOCUMENTS DELETING DOCUMENTS

10. COMMON CONTINUING REVIEW APPLICATION ERRORS WAITING TO SUBMIT A CONTINUING REVIEW BECAUSE ANOTHER ACTION IS PENDING INCONSISTENT ENROLLMENT NUMBERS FROM ANNUAL REVIEW TO ANNUAL REVIEW SUBMITTING WITHIN 4 WEEKS OF STUDY EXPIRATION CRMS REPORT IS INCONSISTENT WITH THE ENROLLMENT CHART (SECTION 4, Q.3)

Contact The Help Desk at 410-502.2092 or jhmeirb@jhmi.edu Thank you Letrice Gant