№ lp_2_1_19557
File format: docx Character count: 17288 File size: 51 KB
Procedural document outlining regulatory and operational requirements for documenting delegated study responsibilities and personnel credentials within ULACNet clinical research sites.
Organization: US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet)
Document type: Guidance document
Subject: Delegation of Tasks Logs (DTLs) and Registration and Credential Repository (RCR) procedures
Applicable to: ULACNet clinical research studies
Regulatory framework: Good Clinical Practice (GCP), Food and Drug Administration (FDA), National Cancer Institute (NCI) requirements
Related entities: Lead Academic Organizations (LAOs); DCP Regulatory Contractor
Scope: Accruing clinical research sites participating in ULACNet protocols
Referenced standards: ICH GCP E6 R2; FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects
Purpose: Requirements and procedures for initiation, completion, submission, review, and maintenance of DTLs and RCR registrations
Audience: Site principal investigators, investigators, sub-investigators, and clinical research personnel involved in ULACNet studies
Price: 8 / 10 USD
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