Regulatory Support

Our team works closely with study teams to help navigate the regulatory processing requirements for human research studies. Our services span from processing initial regulatory study documents and initial submissions to the Institutional Review Board (IRB), to ongoing regulatory maintenance activities (e.g., IRB renewals, SAE submissions) to study closure.

Initial submission to the IRB:

• Initial consent form(s) development (using Sponsor-provided draft);
• Any required ancillary committee submissions (e.g., radiation safety, biosafety, etc.);
• If using central IRB (e.g., Advarra, WCG, Alpha, etc.): HRPP request to use external IRB, initial external IRB submission;
• If using local IRB: initial Yale IRB submission;
• Tracking of submission progress and facilitation of any requests for information/revisions;
• Processing and filing of of the initial IRB approval;
• Confirmation of institutional training compliance for all study team members listed in submission.

Initial essential documents processing and electronic regulatory binder (“eReg Binder”) setup:

• Essential Documents: our team will create, route for signature, file, track and follow-up as needed on all required essential documents (e.g., 1572, financial disclosure forms, Protocol and Investigator Brochure signature pages, CVs, Medical Licenses, Delegation of Authority Log, etc.);
• eReg Binder Set-up: We create the electronic-Investigator Site File (eISF) in Advarra eReg and upload all IRB approved documents related to the initial submission. We confirm the staff list and organizations and facilitate access to eReg for team members.

Ongoing regulatory support:

• The following activities are included in ongoing regulatory support:
• Maintain eRegulatory binders, including staff & site/facility credentialing and regulatory reporting (protocol deviations, responses to requests for clarification, process IRB acknowledgement);
• Assist in preparation for monitoring visits, including addressing any regulatory action items that are communicated during the visit and/or in the follow up report and providing external monitors temporary access to our eReg system to for their review.
• Respond to sponsor requests for regulatory information/documents;
• Process changes in study regulatory documents;
• Assist with managing IND safety reports;
• Provide ongoing trial-specific regulatory advisement & guidance to ensure study compliance (for general regulatory compliance questions –contact our Regulatory Affairs department).

Ad Hoc Ongoing Regulatory Support:

We will also perform the following activities as requested:

• Protocol Amendment processing;
• Regulatory preparation and submission for annual IRB continuing reviews and IRB closure;
• Submission of SAEs per reporting policies;
• Assist in preparation for an audit (e.g., FDA audit)
• Regulatory consultations

• It’s critical that the elements within the informed consent form are consistent with the budget and Clinical Trial Agreement (CTA)
• Elements within the consent should be reviewed, confirmed with the sponsor and communicated to your Office of Sponsored Projects (OSP) rep and budget analyst.
  
• To ensure budget / consent / CTA consistency, the following should be considered:
  • If the sponsor is offering home health services/decentralized clinical trial services, is the PI going to utilize this option?
  • If telehealth options are offered (not regular phone call follow up visits), will the PI utilize this option?
  • Are you providing stipends or reimbursements for travel expenses? Our recommendation is a fixed stipend amount per visit as this reduces the burden on participants.
  • Consider how any stipends or reimbursements will be distributed; will you be using any Sponsor-provided third party vendors? All stipend and reimbursement decisions should be made early on to facilitate smooth IRB submission and budget negotiations
  • Does the consent state that any other services or items are being provided to the participant, e.g. sharps containers, mini fridge for storing IP, small ice chest to transport IP, iPhones/tablets for completing PROs, rescue medications, etc.? If these items are listed in the consent form AND the study team is going to be providing these to the participant, these must be captured and accounted for in both the CTA and budget.

• Local HRPP office, including FWA information and external IRB agreements
• Advarra eReg (eISF) access and information
• Standard Operating Procedures – please contact the regulatory team and these can be provided to you