The OCRPRO mission is to facilitate the clinical research enterprise by providing protocol development and regulatory, clinical trials management and safety oversight for NIAID intramural and Division of Clinical Research programs.
OCRPRO originated in June 2001. Staff consists of a branch chief, clinical research oversight managers, and administrative support personnel. A contract with Leidos Biomedical Research provides staffing for key areas of the support that the branch provides. Each oversight manager is responsible for an area of research support and oversees the contract staff’s work.
Conduct regulatory and safety reviews of protocols, informed consents and case report forms and provide recommendations to enhance safety provisions based on study risks
- Provide oversight for adverse event, serious adverse event and unanticipated problems documentation, recording and reporting requirements
- Evaluate serious adverse events for regulatory reporting requirements and submit IND Safety Reports to the FDA, investigators and other entities per requirements
- Review the safety aspects of IND Annual Reports for accuracy and completeness
- Conduct safety reviews of accumulating safety data for FDA regulated studies to identify safety signals
- Manage the DCR Data and Safety Monitoring Board, Safety Monitoring Committees and Independent Safety Monitors
- Provide safety training to study staff to facilitate accurate and complete documentation, recording and reporting of safety events
- Monitors clinical trials (by reviewing medical records and other source documents) to ensure that human subjects are protected, validates the integrity of the data collection and recording process, and ensures compliance with all appropriate regulations and the ICH/GCP Guidelines and performs site assessment visits for new sites as needed
- Provides services such as reviewing source document templates, developing case report forms, protocol study manuals, randomization and treatment allocation codes, guidance documents, and subject study numbers, and GCP training for the investigators in the intramural community and those studies sponsored by the NIAID intramural programs, both domestic and international
- Reviews draft informed consent forms (ICFs), and protocols, focusing on the "Data Management Plan," "Protocol Monitoring Plan," and "Plan for Use and Storage of Biological Samples" sections of the protocol as well as on the study procedures, table of events/study schedule, study agent/dosing requirements, and feasibility of procedure implementation, when applicable
The goal of this program is to facilitate protocol development from concept to approval by providing consultation with protocol and informed consent requirements and assistance with writing these documents, as well as navigating investigators through the steps required for approval, depending on the type of research project. The PN/PDP consists of protocol navigators and medical writers teamed up per protocol to provide the needed support. NIAID intramural investigators can voluntarily request the PN/PDP services. The objective is to decrease burdens of the regulatory and administrative requirements on the intramural NIAID clinical research infrastructure.
- Identify the research services required for a particular protocol.
- Establish a reasonable timeline to navigate the protocol through various research entities.
- Identify personnel early in development who can facilitate the process.
- Engage with writers in the review of documents for content and applicability of current policies and guidelines.
- Work with researchers to route protocol documents through all the necessary reviews and approvals.
- Keep other study staff on track and engaged in the research project for early planning purposes.
- Draft and revise clinical research protocols from the investigator-initiated concept through receipt of IRB approval.
- Ensure protocol and consent documents meet applicable internal and external regulatory requirements.
- Assist with responding to stipulations from review committees.
- Other duties may include amendment drafting, creating NIH specific appendices, and providing other editorial support.
In support of IND applications, the Regulatory Group
- Prepares and submits Food and Drug Administration (FDA) meeting requests and supporting material packets
- Prepares and submits Investigational New Drug (IND), Investigational Device Exemption (IDE), and Master File (MF)applications and subsequent submissions for lifecycle maintenance, in electronic Common Technical Document (eCTD) where applicable
- Prepares IND/IDE/MF annual progress reports
- Prepares Investigator's Brochures
- Reviews protocols to ensure compliance with Food and Drug Administration (FDA) regulations, Good Clinical Practice guidelines, and National Institutes of Health policy
- Acts as a liaison between the principal investigator and FDA
In support of the NIAID Deputy Director for Clinical Research, the Clinical Research Working Group
- Prepares the agenda and minutes for the NIAID Clinical Research Subcommittee (NCRS)
- Provides administrations and structure to working groups of the NCRS
- Evaluates new or modified federal and NIH clinical research regulations and policies for impact on NIAID research
- Updates trans-NIAID clinical research policies as needed