Clinical Data Management Plan Template - External Facing - Approval Signatures

Aug 31, 2026

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Clinical Data Management Plan (CDMP) template for studies using an Electronic Data Capture (EDC) system, intended for Lead Data Managers and Principal Investigators. The template must be customized to the protocol, special study needs, and the data capture system requirements, with editable or removable sections as necessary. It includes best-practice guidance on deleting instructional text, updating sponsor references, retaining the CDMP identifier in the footer, and removing the tool summary before use, supported by approval signature blocks and a structured content outline.

LanguageEnglish

CategoryForms

FormatDOCX

Pages29

Reading Time10 min

AccessFree to download

APPROVAL SIGNATURES

TABLE OF CONTENTS

ABBREVIATIONS AND DEFINITIONS

DYNAMIC REFERENCES

1 Introduction

2 The Electronic Data Capture (EDC) System and the Underlying Clinical Database

3 Network Directories

4 Data Validation Process

5 Verification of EDC Setup and Implementation

6 Data Entry and Data Cleaning

7 Loading Electronic Files

8 Medical Coding

9 EDC Exported Database

10 Reports

11 SAE Reconciliation

12 Changes to a Production EDC

13 Database Closure

14 Data Archiving and Provision of Final Materials to Sponsor

Tool Summary Sheet Tool: Clinical Data Management Plan Template – External Facing Purpose: This Clinical Data Management Plan (CDMP) template may be employed for studies using an Electronic Data Capture System (EDC), unless another template has been agreed upon. Audience/User: Lead Data Managers and Principal Investigators of studies using Electronic Data Capture Systems Details: The template should be customized to the protocol, the study’s special needs / circumstances, and the requirements of the data capture system. Sections may be edited or deleted as needed. As an alternative to this detailed template, individuals may prefer to reference the ‘Data Management Considerations (Condensed)’ tool, which is available in NIDCR’s Toolkit for Clinical Researchers ( HYPERLINK "https://www.nidcr.nih.gov/research/human-subjects-research/toolkit-and-education-materials" \o "Toolkit & Educational Materials " http://nidcr.nih.gov/research/toolkit). This considerations tool lists important issues to consider when evaluating a group’s ability to electronically capture and validate clinical research data, and summarizes the wide array of data management tasks required. The tool could also be used to suggest headings and content for a simplified clinical data management plan. Best Practice Recommendations: Items in blue italics and enclosed in braces { } are instructional text that should be deleted prior to approval. Items enclosed in single <> are placeholders. Replace as clarified in the enclosed text. References to “Sponsor” may refer to the funding sponsor or to the study PI, depending on the context of the sentence and on the decisions at the time of CDMP development. Update the template at the time of implementation to refer to the appropriate party. Please retain the CDMP Template identifier in the lower left hand section of the footer. Remove this Tool Summary Sheet prior to use of this template. Tool Revision History: Clinical Data Management Plan Protocol Title: Protocol Number: <#> Summary of Changes: Version Clinical Data Management Plan Protocol Title: Protocol Number: <#> APPROVAL SIGNATURES {Ensure that the CDMP version number and date are correct before providing the document to the primary signatory.} _______________________________________________________ ____________________ Principal Investigator: Date ______________________________________________________ ____________________ Project Data Manager: Date TABLE OF CONTENTS TOC \o "1-2" \h \z HYPERLINK \l "_Toc471471355" APPROVAL SIGNATURES PAGEREF _Toc471471355 \h 4 HYPERLINK \l "_Toc471471356" TABLE OF CONTENTS PAGEREF _Toc471471356 \h 5 HYPERLINK \l "_Toc471471357" ABBREVIATIONS AND DEFINITIONS PAGEREF _Toc471471357 \h 6 HYPERLINK \l "_Toc471471358" DYNAMIC REFERENCES PAGEREF _Toc471471358 \h 7 HYPERLINK \l "_Toc471471359" 1 Introduction PAGEREF _Toc471471359 \h 10 HYPERLINK \l "_Toc471471360" 2 The Electronic Data Capture (EDC) System and the Underlying Clinical Database PAGEREF _Toc471471360 \h 11 HYPERLINK \l "_Toc471471361" 3 Network Directories PAGEREF _Toc471471361 \h 12 HYPERLINK \l "_Toc471471362" 4 Data Validation Process PAGEREF _Toc471471362 \h 13 HYPERLINK \l "_Toc471471363" 4.1 Univariate Alerts PAGEREF _Toc471471363 \h 13 HYPERLINK \l "_Toc471471364" 4.2 Multivariate and Cross-module Alerts PAGEREF _Toc471471364 \h 13 HYPERLINK \l "_Toc471471365" 5 Verification of EDC Setup and Implementation PAGEREF _Toc471471365 \h 15 HYPERLINK \l "_Toc471471366" 5.1 System Specifications PAGEREF _Toc471471366 \h 15 HYPERLINK \l "_Toc471471367" 5.2 User Acceptance Testing PAGEREF _Toc471471367 \h 15 HYPERLINK \l "_Toc471471368" 6 Data Entry and Data Cleaning PAGEREF _Toc471471368 \h 17 HYPERLINK \l "_Toc471471369" 6.1 Pre-requisites for Site Data Entry PAGEREF _Toc47147136

FAQs

Who is the intended audience for the Clinical Data Management Plan template?

The template is intended for Lead Data Managers and Principal Investigators of studies using Electronic Data Capture Systems.

What customization is required before using the template?

Customize the template to the protocol, the study’s special needs or circumstances, and the requirements of the data capture system; sections may be edited or deleted as needed.

What should be done with instructional text and placeholders in the document?

Delete instructional text shown in blue italics within braces, and replace placeholders enclosed in single angle brackets according to the enclosed clarification text.

Aug 31, 2026

Upload by Bintang