Quality assurance and documentation in clinical trials

[Guest guest]

Dear participants,

I will be covering this topic under two stages. Stage I will have discussion regarding:

Stage-I: Documentation in clinical trials

· ICH-GCP terminology

· Important consideration

· Documentation pertaining to participant screening, informed consent, enrollment, follow-up visits, source notes, case report forms, patient tools, safety reporting (SAE), essential documents, patient confidential records, and other documents.

· Ethical obligations- audits, inspections, SIV, SMV, SCV.

and stage II will have following sub-topics:

Stage- II: Quality assurance in clinical trials

· ICH-GCP terminology

· Document preparation

· Roles and responsibilities of clinical trial team personnel in maintaining quality.

· Data verification

· Quality control

· Corrections and Amendments

· Regulatory audits/Inspections

· Data clarification and resolution

· Document retention

Tarun Wadhwa