Six Startup Questions to Discuss with Planned Sites Before Activation
Site startup for a clinical trial will always be a challenge. Why? While driving the study forward and gathering cross-functional expertise to operationalize a successful study, site startup is comprised of many unexpected hurdles that may get in the way of meeting clinical development milestones.
Site activation is not an easy or rapid process. Based on a recent experience where the site was held at a well-known institution, it can take approximately nine months to activate even at such an institution using local Institutional Review Boards (IRB). In this example, the institution required multiple committees to review and grant approval to activate the site. Alternatively, even sites willing to use a central IRB with less committee-required approvals can take an ample amount of time.
When navigating site activation, the following questions will help you manage approvals and contracts, stay on top of the activation process, and maintain development timelines, all while staying ahead of those common hurdles.
- What approvals will need to be in place for your institution to activate your site?
- Outside of local IRB approval, committee requirements are contingent on the institution. Committees may include boards that determine if team bandwidth for new study is acceptable, and require approvals by a scientific review board, feasibility committee, and other institution-specific approvals.
- What are the meeting dates for each committee?
- If committees are meeting once a month, it will be crucial to ensure the institution receives everything required to submit in time for the planned meeting. Additionally, unforeseen delays with one committee may cause a ripple effect if the planned meeting date is missed, therefore impacting all subsequent meeting dates.
- What documentation is required for submission to each of these committees and what is the due date based on each meeting?
- In some cases, for initial study submission, some institutions may require final (or near final) manuals or plans submitted alongside protocol, consent, and Investigator’s Brochure before the site will consider the study for participation. This may mean vendors will need to be identified and selected well ahead of time (i.e., laboratory manuals) to operationalize the process.
- Can submissions occur in parallel with contract and budget negotiations?
- Contract execution can take four to six months or longer and is often executed by a separate functional group at the site. When working through contract and budget execution, aim to begin review of the Clinical Trial Agreement (CTA), provide templates as soon as the site will allow to get a head start on this process as multiple functional team members may need to provide feedback, and ensure payment terms language is part of the draft review.
- Following agreement on which template should be used (i.e., site, Contract Research Organization, or sponsor), ensure it is clear if any additional agreements may be required to partner with the site (i.e., data privacy, home health services, etc.)
- Begin discussions internally on coordination surrounding escalations regarding out of fair market range for budgets and needs for sample storage.
- Align with site contracts and budget team to communicate timelines and confirm when team will be out of office for paid time off.
- What other site-specific formalities may be needed to activate?
- It may be beneficial to work with each functional group on site to gather feedback, discuss the process, and ensure awareness between all parties related to study timelines.
- Pharmacy: Pharmacists will be crucial to provide feedback following review of the Pharmacy Manual and associated documents. Additionally, if a pharmacy needs to create study specific institution documents per standard operating procedures, time must be built in.
- Laboratory: Partnering with the laboratory group is crucial to understand facility limitations surrounding the batching and shipping of samples, storage, supplies required, and review of study forms for continuity.
- Data Management: Electronic Data Capture (EDC) access and training requirements for activation
- Trial Master File (TMF): Aim to start collection of essential documents as soon as possible to avoid last minute delays surrounding Investigational Product Release (IP) as well as timeframes needed for the drug to arrive on site.
- Site Feedback: Including your investigators and study coordinators in planning activities is ideal to help prevent unforeseen operational limitations and patient burden that may result in amendments.
- Once Site Initiation Visit (SIV) occurs, will the site be able to begin screening or are there any other internal activities that must occur before the site is deemed active?
- Sites may not plan to activate immediately after the SIV occurs as there may be institution-specific requirements needed to be in place before site will begin screening participants. It will be important to confirm the process.
- Requesting dates ahead of time for the SIV will also be key for preventing delays in activation due to scheduling conflicts between multiple team members.
The important lesson for site startup is remembering every institution is different, and this understanding requires proper planning. Asking critical questions and providing clear communication with the site from the onset is key to planning and meeting deliverables and helping to enable clinical research success.
Questions about your site activation? Or curious about how to establish a great site relationship from the beginning? Contact Halloran to discuss your challenges and opportunities. We’re here to support you.