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Study Tips & Advice
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Timeline: Develop a timeline and allow sufficient time for Scientific, GCRC and CCI Review
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Training: Thoroughly train and document protocol specific training provided to study staff.
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PI Responsibilities: Review and ensure compliance with all responsiblities outlined in the CCI's PI Responsibilities policy.
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Study Procedures: know all the study procedures and ensure adequate resources to complete them
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Document Organization: Develop and implement a system to manage all study documents.
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Additional Contact: Be sure to have the person responsible for maintaining study documentation is listed as an additional contact with the CCI. This person will receive copies of all CCI correspondence.
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Test Run Document Management: Be sure the system in place for study organization and documentation can be easily maintained and subject confidentiality ensured.
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EQuIP Tools & Templates:Review the tools and templates on EQuIP's website; customize and implement those tools that will help your team effectively manage your study.
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Informed Consent: Ensure informed consent is obtained and documented as outlined in the protocol. Remember, Informed Consent is an ongoing process.
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Protocol Adherence: Ensure the investigation is conducted according to the investigational plan
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Deviation Reporting: Routinely review protocol processes and documentation. Identify and report deviations as required by CCI and sponsor policies.
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Amendments: All proposed changes to the investigational plan must be reviewed and approved by the CCI (and sponsor if applicable) prior to implementation.
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Completion Form: Complete and submit a completion form to the CCI.
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Document Retention: Review CHB's policy on document retention and your sponsor's, if applicable. Ensure all study documents will be retained properly.
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PI Responsibilities: Ensure all documents are on file, completed and signed as required.
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Drug/Device Accountability: If applicable, complete inventor of drugs and devices - all drugs and devices must be accounted for. Unused drug/devices should be either returned to the sponsor or destroyed (as directed by the sponsor).
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