The Office of Sponsored Programs (OSP), the Office for Clinical Research (OCR), and the Institutional review Board (IRB) collaborated to document the most common causes of delays in clinical trial approvals at Emory. As a result of this collaboration, OSP, OCR, and the IRB have created the following “Tip Sheet” as a resource for departmental personnel responsible for routing clinical trials in an effort to minimize delays in the clinical trial approval process. The tip sheet, which is printed below, as well as a Frequently Asked Question (FAQ) document, can also be found on the web here.
IRB – Most common reasons that cause delays in IRB approving a clinical trial
1) Consent Tips
- Please use the consent template from the IRB website to ensure the language is the most current version. This will ensure that your consent is using the most up-to-date template language.
- Use the most current subject injury language (also known as “compensation for research-related injury) word-for-word from the IRB consent template. Any variations may cause document inconsistency and possibly delay approval.
- Keep it simple – subjects best read and understand consents written at an 8th grade level required by IRB. Use the Flesch-Kincaid Grade Level tool in Word.
2) Proofreading Tip: customize each document based on study needs, but cut and paste with care. Delete the “comments” bubbles in the document margins and delete the unused options in the template before submitting to IRB for review.
3) Data Safety and Monitoring Plan Tips:
- Every study must have its own Data Safety and Monitoring Plan (DSMP).
- Please complete the appropriate eIRB section on the study’s DSMP.
4) IND Tip: For an FDA-regulated study, please upload authentic FDA letter documenting IND# or protocol with IND# listed or, if applicable, FDA exemption letter into eIRB.
5) eIRB Tips:
- Please remember to click both the “Finish” button and the “Submit” button at the end of the eIRB application. Otherwise the application is not forwarded for department approval or to IRB.
- If your study need Conflict of Interest (COI), Radiation Safety, or Biosafety approval, apply to those committees separately using the process in place. This must also be noted on the “Required Reviews” section in eIRB. Submit to all committees concurrently.
6) Training Tip: Send CRC for eIRB training. there is a wealth of information in eIRB, but the software is difficult to navigate and drill down to what is needed.
OSP – Most common reasons that delay clinical trial approval
1) Routing Tips: Concurrent review by OCR, OSP, and IRB is encouraged. Therefore, there is no need to wait for IRB approvial or OCR review before submitting to OSP via EPEX, as this will result in significant delay. Documents must be received from PI, not the sponsor.
2) Routing Package Tips:
- For a list of required documents comprising a complete routing package, go to the OSP website here. OSP cannot process unless they have all required documents.
- OSP needs documents (including the contract) in an editable format. Please submit a Word or Excel (non pdf) version.
- Be sure to include sponsor contact information in case OSP needs to request changes to the proposed agreement.
- Please include all collaborators (other investigators) upon submission to assure front-end approvals from each collaborator’s department are obtained.
3) Timing Tip: Have study staff route to OSP as soon as protocol and other study-related documents are received from the sponsor.
OCR – Most common reasons that delay clinical trial approval
1) Routing Tips:
- Concurrent review by OCR, OSP, and IRB is encouraged; please submit simultaneously to all three ORA units.
- Please do not wait for IRB submission or approval before submitting to OCR via OCR@emory.edu and OSP, as this will result in significant delay.
- If a protocol is amended and routed to IRB, then it should be routed to OCR if the budget and/or billable items and services are affected.
- For a list of required documents comprising a complete routing package, go to OCR. OSP cannot process unless they have all required documents simultaneously.
- Answering yes to EPEX Q#15 will trigger workflow for OCR & OSP reviewers (only) after proposal is saved and routed.
- Notify OCR if the study intends to utilize the Clinical Interaction Network (CIN).
2) Proofreading Tip: Please review the budget and PRA carefully before approving.
3) Timing Tip: Respond to questions or requests for approval within 24-48 hours to facilitate approval.