Durham Research Collaborative, LLC

Wisdom Wednesday! Informed Consent. || #clinicalresearch #ichgcp #cra #goodxpractice #goodclinicalpractice #clinicaltrials

Wisdom Wednesday! Informed Consent. || #clinicalresearch #ichgcp #cra #goodxpractice #goodclinicalpractice #clinicaltrials

Wisdom Wednesday! Informed Consent. || #clinicalresearch #ichgcp #cra #goodxpractice #goodclinicalpractice #clinicaltrials

Delegation of Authority Log - PI signature date || #clinicalresearch #ichgcp #cra #goodxpractice #goodclinicalpractice #clinicaltrials

National Native American Heritage Month! Reposting: https://lnkd.in/ebe3qsQ4

#clinicalresearch #ichgcp #cra #goodxpractice #goodclinicalpractice #clinicaltrials

The delegation of authority log is an essential document that often creates a lot of confusion. For instance, it is important to note that the tasks delegated should be tailored to the person’s training and role in the study. So, it is unusual and unrealistic to see a single staff member delegated to every single task. Typically, the PI and Sub-Is are delegated to critical tasks ranging from obtaining informed consent, confirming participant eligibility, interpreting diagnostic results such as labs, imaging, and ECGs, and assessing adverse events. || #clinicalresearch #ichgcp #cra #goodxpractice #goodclinicalpractice #clinicaltrials

In clinical trials and research studies, the buck stops with the PI! Therefore, the PI must provide the necessary supervision to all study staff. The supervision may include, but it not limited to holding regular staff meetings to discuss study progress, hold training and refresher sessions, review recruitment and enrollment logs, review adverse events and other safety information, review new study information, review protocol deviations, and so on. Refer to E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) section 4.2.5 || #clinicalresearch #ichgcp #cra #goodxpractice #goodclinicalpractice #clinicaltrials

Lack of training documentation is a common audit and inspection finding. So, it is important to ensure all study staff have completed and documented their training. Therefore, you should develop a tracking system for all persons delegated study responsibilities. It can be a spreadsheet or if you have access to an electronic regulatory system, it may be able to alert you to missing or expired training. How do you ensure all staff are fully trained? Refer to E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) section 4.2.4 || #clinicalresearch #ichgcp #cra #goodxpractice #goodclinicalpractice #clinicaltrials

All signed Informed Consent Forms (ICFs) should remain on file with the study records as they are legal documents. Even when the participant signs a new updated ICF. Unfortunately, I have run across too many instances where previously signed ICFs have gone missing or have been misplaced. This is another common finding during audits and inspections. Take care to ensure good record keeping practices are implement at your site to ensure all signed ICFs remain available throughout the course of the study. || #clinicalresearch #ichgcp #cra #goodxpractice #goodclinicalpractice #clinicaltrials