Streamlining the IRB submission process through collaboration
By Dawn Pope,
Chief Operating Officer
Effective collaboration with your institutional review board can help prevent delays in start-up activities that can cost sponsors and CROs valuable time and negatively impact site enrollment activities. In this quarter’s newsletter, Copernicus Group IRB’s Director of Client Services, Dawn Pope, explores ways Sponsors, CROs and sites can take advantage of the latest collaborative tools to keep the channels of communication open with the IRB, streamlining the submission process and shortening review timelines.
Before Protocol Submission
Use these methods to ensure effective communication, efficient IRB reviews
As an internally paperless IRB, we see how dramatically technology can impact efficiency. At one time, Sponsors and CROs had to rely on email and telephone communications to check the status of their IRB submissions, and investigator sites had to rely on couriers to provide their IRB approval documents. Using CGIRB Connexus®, our electronic document management system, Sponsors, CROs and sites have real-time access to their submission’s review status and can submit and retrieve documents with the click of the mouse. They get instant automated receipts for each submission and notification when approvals are granted. Fully utilizing Connexus® permits Sponsors and CROs to manage every aspect of their sites’ submissions in one organized workspace, allowing them to track submissions, sort and retrieve documents and grant study workspace access to colleagues.
Taking advantage of technology like CGIRB Connexus® can help to avoid delays and improve IRB review timelines
Prior to submitting a study, become familiar with the IRB’s electronic capabilities.
- CGIRB provides CGIRB Connexus® training. If you are unfamiliar with the system, be sure to attend a training session to learn about all of the system’s capabilities.
- Do you want to invite your colleagues to have access to your study workspace? If so, invite them to participate in training as well. CGIRB can arrange group training sessions via webex to accommodate your team.
- Will sites be receiving hard copies or will the study be completely paperless? If no hard copies will be provided, a CGIRB administrator can help you to notify sites to register for access to their documents and encourage them to attend training.
Bringing the right people on board at the beginning of the submission process will help to ensure that information is consistently delivered to all stakeholders. Developing clear communication channels is an important step in streamlining processes. Much of the information in the following section is covered during study initiation calls.
As you begin the submission process, remember to consider the following:
Establish Study Contacts
- Identify the primary contact for the study and provide their contact information to the IRB. Also identify and provide contact information for:
- Anyone who should be copied on all documents
- Anyone who will be contacted for questions regarding the protocol
- Anyone who should be contacted for questions regarding Principal Investigator (PI) applications
- Identify a secondary contact as backup in case the primary contact is unavailable and provide their contact information
- Are you knowledgeable about the IRB and their procedures? If not, call and introduce yourself. Ask questions regarding the IRB submission requirements and timelines. Establish a contact within the IRB to work with throughout the submission process.
- Are there any unique qualities about your study that you would like to discuss with the IRB prior to your formal submission? CGIRB staff may be able to provide guidance on how to prepare your submission to address any concerns or issues prior to the IRB meeting.
- CGIRB offers study-initiation calls to go over study-specific expectations and answer questions prior to the scheduled IRB meeting to work through the details of your submission. Invite colleagues to join the meeting to familiarize themselves with the CGIRB team and learn about the review process.
IRB Submission Requirements
Understanding what the IRB requires to perform the review process and providing complete information will help cut down on follow-up work.
As you gather the documents for your submission, remember to consider the following:
- Informed Consents
- How many Informed Consents will there be? Are there any sub-study consent forms that will only be used for certain sites? CGIRB has online templates to use for Informed Consent development.
- If vulnerable populations are involved, are the appropriate assent forms ready for IRB review? CGIRB has a list of FAQs regarding assent to assist you.
- Will the Sponsor’s legal department have to review changes made by the IRB? If so, customized templates can be negotiated with the IRB prior to study submission.
- Will translated ICFs or other study information be allowed? If so, will CGIRB provide translation services or will the sponsor provide certified translations of CGIRB-approved ICFs?
- Are there any specific HIPAA language considerations? If yes, discuss the considerations with CGIRB in advance to avoid delays during the review process.
- Subject recruitment/retention materials or advertisements
- Will there be any subject recruitment or advertisements submitted? If so, remember to submit them with the protocol.
- If sites have their own advertisements, will these require sponsor/CRO approval prior to submission??
- If a third party will be preparing recruitment items, will they need access to Connexus® to help with the submission of these items for IRB review?
- Submission and Forms
- CGIRB will answer any questions you may have regarding Principal Investigator application requirements during your study initiation call. Be certain to use the most current version of IRB forms by downloading them directly from www.cgirb.com.
- Consider how investigator documents will be submitted to CGIRB. Will they be coming from the Sponsor, the CRO, or individual sites? Explain the process to your CGIRB team during the study initiation call.
- Ensure that each investigator is trained in GCP (or other IRB requirements regarding education and training). CGIRB can provide resources (CITI Training) for research-naïve sites.
- Are there any conflicts of interest for Principal Investigators involved in the study? If so, CGIRB has a form for the PI to complete and can provide guidance.
- Communicate with sites or others on your project team to assure that they understand that complete submissions ensure timely turn around and incomplete documents that are submitted will delay the review process.
- Will there be any pediatric subjects or other vulnerable subjects enrolled? If so, are there special protections in place?
- Ensure that sites are aware of applicable state laws regarding research.
After Protocol Approval
Keep the lines of communication with the IRB open after the study has been approved
Continuing to communicate with CGIRB after the study has been approved is important. Prompt safety reporting and notification of changes to research are vital to subject protection.
During the study maintenance phase, there are different IRB requirements to consider:
- Unanticipated problems
- How will IND Safety reports, if any, be submitted to the IRB during the study? CGIRB encourages submissions directly from the sponsor rather than individually from each investigator.
- How will the reporting of Serious Adverse Events and Protocol Deviations be handled during this study? Will there be a standard reporting form?
- Are you familiar with the IRB’s requirements for which UPs require reporting? If not, your CGIRB contact will provide guidance.
- Other Maintenance Submissions
- Remember to notify CGIRB when staffing changes occur in order to ensure that notifications will be delivered to the correct study contacts.
- Will there be any Clinical Investigator Brochure updates? If so, provide them to CGIRB in a timely manner.
- Is there a process in place that allows for prompt communication of any changes in the research to CGIRB, such as modifications or amendments? Are you familiar with the IRB’s review process for reviewing materials submitted after initial review? If not, your CGIRB contact will guide you through the submission.
- Are you familiar with the IRB’s Continuing Review process? CGIRB will contact you two months prior to the study expiration date and provide Continuing Review forms.
- Each site is required to submit a study close out form. When CGIRB receives notice of study closure from the sponsor or CRO, study close out forms are provided to sites.
For additional information, contact CGIRB.