Training Program Title

Preparing the Study Specific Documentation

Contributor

Duke University

Training Program Description

This module describes the study-level documentation expected at Duke. It describes the regulatory binder, documents required for all studies, documents required for most studies, and documents that are required depending on the type of study. It discusses standard operating procedures. This module provides guidance for creating the binder or file, maintaining central files, and what should not be included in the documentation to be audit ready.

Competency Keywords

Documentation, Essential documents, Regulatory binder, Source documents

Digital Commons Disciplines

Medical Education

Public

no

Cost to Access

no

Delivery Method

Online

Target Learners

Clinical Research Professionals (other than PI)

Learning Level

Fundamental

Frequency

On demand

Associated Assessment

no

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