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Resources: For Accreditation - Evaluation Instrument
Table of Contents
Regulatory and guidance references
- ICH-GCP: 4.2.1, 4.2.2, 4.2.4, 4.3.2
- VA: VHA Handbook 1200.05, 9
- AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)
Required written materials
- Essential requirements:
- Policies and procedures pertaining to Element II.3.A. that address essential elements.
- The policies and procedures pertaining to Element II.3.A also address the written material requirements for this Element. If the same policies and procedures are provided to researchers and research staff, simply reference those documents in the application for this Element. If there are additional materials, such as an Investigator Handbook or Web pages for researchers, that are not included in the materials used to support Element II.3.A, but are in support of Element III.1.D., include them here.
- Researchers are responsible to:
- Ensure that there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment, and space.
- Ensure that research staff are qualified (e.g., including but not limited to appropriate training, education, expertise, credentials and, when relevant, privileges) to perform procedures assigned to them during the study.
Common types of materials that may be used to meet the element
- Researcher manual
- When conducting a research study, researchers have the resources necessary to protect human participants, including:
- Adequate time for the researchers to conduct and complete the research.
- Adequate number of qualified staff.
- Adequate facilities.
- Access to a population that will allow recruitment of the necessary number of participants.
- Availability of medical or psychosocial resources that participants may need as a consequence of
- the research.
- A process to ensure that all persons assisting with the research are adequately informed about the protocol and their research-related duties and functions.