Summary
Highlights
The webinar begins with an introduction to the topic of IRB and Regulatory documentation, highlighting its critical aspects in clinical research. The presenters, Emily Door and Roshana Rothwell, share their professional backgrounds and roles within the CTN, setting the stage for the discussion.
Roshana outlines the webinar's objectives: identifying critical aspects of IRB oversight, understanding appropriate regulatory documentation, and examining roles in reporting progress to regulatory bodies. This section also delves into the historical milestones influencing ethical clinical research, including the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report, emphasizing their foundational principles like voluntary participation, informed consent, minimization of risk, and respect for persons.
This part explains the primary function of the IRB – participant protection. It details how IRBs ensure risk-benefit analysis, equitable participant selection, adherence to Belmont principles, and special protections for vulnerable populations. The structure of an IRB, including its diverse membership requirements as stipulated by the Code of Federal Regulations (CFR Title 21 Part 56), is also discussed.
The discussion covers scenarios where IRB review is mandatory, such as investigational drug/device studies and data collection with identifiable information, versus when it's not (e.g., taste tests). Special attention is given to emergency use of test articles without prior IRB approval, outlining strict conditions and post-use reporting requirements to the IRB.
Roshana explains the three types of IRB reviews: initial, amendments, and continuing reviews. Essential documents for submission, like protocols, informed consent forms (including templates, screening, and verbal consents), recruitment materials, and participant handouts, are detailed. The importance of submitting consent templates to the CCC for review before IRB submission to ensure compliance is emphasized.
This section outlines the extensive responsibilities of a sponsor, including monitoring investigations, informing regulatory bodies of adverse events, selecting qualified monitors, and maintaining accurate records. The role of the Clinical Coordinating Center (CCC) as a Clinical Research Organization (CRO) for the CTN, assisting sponsors with these duties, is also highlighted.
Key regulatory documents for NIDA studies are enumerated, including protocols, informed consent templates, certificates of confidentiality, package inserts, investigator brochures, and fully executed endorsement forms. The significance of the endorsement forms' last signature (CPC) is emphasized as NIDA's 'green light' for the study.
Details on required laboratory documentation, such as CAP certificates and lab reference ranges, are provided. For site documents, the discussion covers DEA registrations, Federalwide Assurance (FWA) numbers, IRB approvals, IRB rosters, OHRP approvals for special populations, and protocol signature pages (investigator agreements).
This segment focuses on documentation for site staff, including Curriculum Vitae (CVs), financial disclosure forms (for IND and non-IND studies), Form FDA 1572, and evidence of GCP and HSPC training. The new requirement for a training documentation form listing all study-specific trainings for each staff member is introduced.
The crucial necessity of obtaining IRB approval for protocol, informed consent, and recruitment materials before study commencement is reiterated. The CCC's policy of not scheduling initiation visits without IRB approval is mentioned.
Emily discusses the responsibilities of lead investigators and nodes, including compliance with regulations, obtaining and maintaining IRB approvals, and assisting sites. She highlights the need for maintaining regulatory documents via RTS and a physical binder, and the importance of having an FWA number for each research site.
Key considerations when serving as a lead or local node in a multi-site trial are explored, such as IRB expectations for principal investigators, educational requirements, amendment policies, review timelines, and any additional documentation required by the lead institution's IRB for multi-site studies.
Emily provides guidance on accurate document submission, including protocols, informed consent templates, CRF manuals, and site monitoring plans. She also details specific reporting requirements for lead nodes, such as notifying their IRB of safety reports from other sites and including multi-site enrollment data during continuing reviews.
A brief overview of internal reporting to various CTN entities (NED, CCTN, PRB, DSMB, CCC, DSC) and external reporting to IRBs, DEA, or FDA is provided.
Roshana explains the Regulatory Tracking System (RTS) as the primary method for submitting documents to the CCC. She outlines the step-by-step process: scanning and naming documents according to convention, logging in, selecting the correct document type (emphasizing accuracy to avoid rejection), completing prompted fields, and uploading.
The RTS review process by protocol specialists is detailed, focusing on verifying document content, correctness of naming convention, and proper association with the intended person. Common errors like uploading blank files or associating documents with the wrong person are discussed, along with the process for document rejection or approval feedback.
The importance of adhering to the naming convention guide for documents like CVs, especially regarding expiration dates, is highlighted for better organization and tracking. The requirement for documents to be PDF files (under 6 megabytes) and the rejection of other formats (JPEG, DOC, DOCX) are communicated.
Detailed instructions are given for submitting Forms 1572 and Investigator Agreements (IAAs): original wet copies mailed to the CCC, PDF versions uploaded to RTS, and copies kept in the regulatory binder. Staff signature logs should be uploaded within 90 days and updated/resubmitted with any staff changes. Guidelines for GCP and HSPC training certificates, including acceptable institutional training and date formats, are also provided.
The webinar concludes with a review of the critical aspects discussed regarding IRB oversight, compliance, required documents, and appropriate regulatory documentation practices. The floor is then opened for a question and answer session, reinforcing that attendees can email questions later if none were submitted during the live session.