DATA MANAGEMENT PLAN (DMP)

STUDY NAME
PROTOCOL NO.	VERSION NO.	DATE
INVESTIGATIONAL PRODUCT NAME
IND NO.	TRIAL PHASE
SPONSOR(S), NAME, AND ADDRESS
FUNDING ORGANIZATION
PRINCIPAL INVESTIGATOR, NAME, AND CONTACT INFORMATION

APPROVED BY:

Project Data Manager Name (Printed)
Project Data Manager Signature	Date

Principle Investigator or Sponsor Name and Title (Printed)
Principle Investigator or Sponsor Signature	Date

REVISION HISTORY

Table 1: Revision History

VERSION NO.	DATE	SUMMARY OF REVISIONS

TABLE OF CONTENTS

1.	INTRODUCTION	3

2.	DATABASES	3

3.	NETWORK DIRECTORIES	3

4.	DATA VALIDATION PROCESS	3

4.1	ALERTS	3

5.	VERIFICATION OF DATABASE SETUP AND IMPLEMENTATION	3

5.1	SOFTWARE SPECIFICATIONS	3

5.2	USER ACCEPTANCE TESTING	3

6.	DATA ENTRY AND DATA CLEANING	3

6.1	SITE DATA ENTRY TRAINING	3

6.2	SOFTWARE PRODUCTION VERSION ACCESS	3

6.3	DATA ENTRY	3

6.4	DATA SECURITY	3

6.5	QUALITY CONTROL	3

6.6	QUERIES	3

7.	ELECTRONIC FILES	3

7.1	ELECTRONIC FILE INTEGRATION	3

8.	MEDICAL CODING	3

8.1	ELECTRONIC FILE INTEGRATION	3

9.	EXPORTED DATABASES	3

10.	EXPORTED DATABASES	3

11.	SEVERE ADVERSE EVENT RECONCILIATION	3

12.	CHANGES TO PRODUCTION DATABASE	3

13.	DATABASE CLOSURE	3

13.1	DATABASE CLOSURE CHECKS	3

13.2	CLOSURE QUALITY ASSURANCE	3

13.3	DATABASE UNLOCK	3

14.	DATA ARCHIVING AND FINAL PROVISION OF MATERIALS TO SPONSOR	3

15.	REFERENCE DOCUMENTS	3

16.	TERMS AND ABBREVIATIONS	3

INTRODUCTION

Describe the study in brief, including the clinical phase and any additional protocol design components not described in the title (i.e., phase 1, randomized active comparator control study of patients with hypercholesterolemia - the study will treat each patient for up to two years).

Describe the purpose of the clinical data management plan (CDMP). Include information about specific data management and the necessary handling practices. Also, include the processes to review, approve, finalize, and modify the CDMP. If staff is going to use additional guidance documents, note them here.

DATABASES

Describe the data capture systems or database software the study will use and the version number. Include any information that links the data program to 21 CFR Part 11 regulations. Also, include any information on the system security, audit trail, electronic signature features, and disaster mitigation. If there is associated ancillary software, note it here (i.e., statistical analysis software). If the server setup that houses the database is a physical location, describe it and any systems that will access the software.

NETWORK DIRECTORIES

Describe all information related to the network directories, including security, disaster mitigation, and structure (i.e., directories and subdirectories) to store the study information. Include a diagram if available.

DATA VALIDATION PROCESS

Describe the electronic edit check validation of the data by the software. If there is a data validation plan, include it here.

4.1	ALERTS

Describe the software system’s capabilities for alerting users to single and multiple-variable data anomalies, including any relational data error alerts. For example, if the user should check a yes/no checkbox and does not, the system will issue an alert. Other examples of possible issues are the confirmation of a reason entered into the appropriate field when staff chooses “Other” in a multivariate field, or confirmation that timing sequences, such as timing between appointments and events, are logical.

VERIFICATION OF DATABASE SETUP AND IMPLEMENTATION

Describe the protocol-specific setup and implementation of the database here, including the documents and procedures used.

5.1	SOFTWARE SPECIFICATIONS

Describe the system-specific specifications and functions for the software (i.e., data entry screens, CRFs). Research staff could be involved in developing these functions and specifications. Include the process for developing, documenting, and approving these specifications and functions. Staff should complete the approval of the specifications and functions prior to user acceptance testing.

5.2	USER ACCEPTANCE TESTING

Users should test the database and software system and document it in a test summary report, confirming that the items in the table below function properly. Add testing items to the table below.

Table 2: User Acceptance Testing System Checks

SYSTEM CHECK	TESTING DETAILS

DATA ENTRY AND DATA CLEANING

6.1	SITE DATA ENTRY TRAINING

Describe site-specific software user training requirements.

6.2	SOFTWARE PRODUCTION VERSION ACCESS

The data manager should detail the process for granting production access to the database.

6.3	DATA ENTRY

Describe what data staff will enter. Specify which staff members will enter the data and if they are on site or separate from the site. Specify which fields are double-entry (this should be consistent with and documented in the protocol). Describe (and attach) any documents that help users with the data entry process.

6.4	DATA SECURITY

Describe the methods and procedures that will assure data security (i.e., limited user access, physical server security, backup and restore processes, and security technologies).

6.5	QUALITY CONTROL

Describe the quality control processes for the databases, including any technological or manual strategies.

6.6	QUERIES

Describe the queries, both software-generated and manual. Describe the alert process and how staff or the software will make any corrections or overrides.

ELECTRONIC FILES

Describe how staff will integrate data files from outside the database with the database (i.e., clinical data). Detail the data transfer schedule, frequency, and format. Also, detail the security procedures to prevent malware during data integration. If staff will store the data before integration, detail the location and security procedures. Detail any procedures to fix issues and the staff responsible. Use the table below to detail the different data types and integration processes. If receiving normal-range laboratory data, detail the receipt and processing procedures.

7.1	ELECTRONIC FILE INTEGRATION

Table 3: Electronic File Integration

DATA TYPE	CRF LOCATION	SOURCE OF DATA	TRANSFER FREQUENCY / SCHEDULE	NEW OR CUMULATIVE	ADDITIONAL INSTRUCTIONS

MEDICAL CODING

Describe the procedures, tools, methods, and conventions for medical coding. Specify the coding dictionary and version number. Specify the medical coding that staff will perform. Specify the frequency of medical coding for each data type and the review schedule. If automated software will perform coding, describe how staff will combine it with manual coding. Include how staff will code events that they must split into more than one record and how staff will code multiple medications. Describe the adjudication and review process of medical coding. Describe the final review prior to database lock.

8.1	ELECTRONIC FILE INTEGRATION

Table 4: Medical Coding

DATA TYPE	SOURCE OF DATA	CODING DICTIONARY	VERSION	ADDITIONAL NOTES

EXPORTED DATABASES

Describe the scope, format, and frequency of the data exports from the database. Detail any predefined or custom coding for exports. Detail If staff needs to use data conversion code for multiple datasets or note “Not Applicable.” Describe the validation process for data conversion. Identify the reference document if data conversion is for public use, as per federal requirement.

EXPORTED DATABASES

List data management reports in the table below.

Table 5: Report List

REPORT	PURPOSE	FREQUENCY	RECIPIENT	HOW RECEIVED

SEVERE ADVERSE EVENT RECONCILIATION

Describe the processes staff will use to reconcile the clinical data database with the safety database. List the data fields that staff will use to compare the two databases and the procedures for handling and documenting any discrepancies.

CHANGES TO PRODUCTION DATABASE

Describe how staff will propose, review, and document changes to the production database, based on any protocol changes. Describe how the lead data manager will evaluate and communicate the changes and the testing process that the staff will conduct. Indicate that the staff will also make changes to the original testing section of this document. Detail the staff members authorized to perform changes.

DATABASE CLOSURE

Describe all processes and staff responsible for closing the database at the completion of the study.

13.1	DATABASE CLOSURE CHECKS

Describe the database checks and procedures required to ensure that the staff has resolved all queries and to ensure that the data is clean. In other words, ensure that the staff enters all CRFs, that the project database meets all of the data dictionary specifications, that the staff includes the status of all subjects, that the value formatting is appropriate, that there is consistency between date fields, and that the staff inputs all signatures.

13.2	CLOSURE QUALITY ASSURANCE

Describe all quality assurance procedures after the study to ensure that the staff detects and corrects all errors before its members lock the database. Detail how staff will receive approval, document, and perform the database lock. If they perform a soft lock, describe the distinction between that lock and the final lock.

13.3	DATABASE UNLOCK

In extraordinary events, the staff will need to unlock the database after they deem it final. Detail the process for unlocking, the justification for unlocking, and the required approvals. Detail the personnel authorized to unlock the database and the procedures for performing and documenting changes.

DATA ARCHIVING AND FINAL PROVISION OF MATERIALS TO SPONSOR

Describe the datasets and the documentation that the staff will archive after the completion of the study. If the study is not to be the sole repository the data, detail what data will go to the outside entity, the format of that data, and how the staff will deliver that data to the outside entity. Indicate if the staff will develop any datasets for public use.

REFERENCE DOCUMENTS

Describe in the chart below any references that are important to the clinical data management of the study, but are not included as a part of this clinical data management plan. These references can include documents signed by someone other than the principal investigator, frequently updated documents, and documents owned by someone other than the principal investigator.

Table 6: Reference Documents

REFERENCE	CONTENT	OWNER	LOCATION CURRENT VERSION STORED

TERMS AND ABBREVIATIONS

In the table below, include definitions for any terms or abbreviations in this document.

Table 7: Definitions

ABBREVIATION / TERM	DEFINITION

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