DATA AND SAFETY MONITORING PLAN

TEMPLATE FOR CLINICAL RESEARCH

[Sponsor Name]

CLINICAL RESEARCH PROTOCOL

[PROTOCOL NAME]

PROTOCOL NO.
VERSION NO.	DATE
INVESTIGATIONAL PRODUCT NO.
IND NO.	TRIAL PHASE
SPONSOR(S) NAME AND ADDRESS
FUNDING ORGANIZATION
PRINCIPAL INVESTIGATOR NAME AND CONTACT INFORMATION:
MEDICAL MONITOR NAME AND CONTACT INFORMATION
COORDINATING CENTER (if applicable)

APPROVED BY:

Principle Investigator or Sponsor Signature and Title	Date

SITE

DATA AND SAFETY MONITORING PLAN AGREEMENT

I have read and understood the data management plan below. In my capacity as Investigator, my duties include: supervising the enrolled study participants to ensure their safety; and providing [PI OR SPONSOR NAME] with complete and timely information. This information will be provided as outlined in this study protocol. All the information relating to this study will be held in strict confidence and this confidentiality requirement applies to all staff at this study site or involved with this study. I agree to maintain the procedures required to perform this study in accordance with Good Clinical Practice principles and to abide by the terms of this data management plan.

PROTOCOL NO.	PROTOCOL DATE
PROTOCOL TITLE

Investigator Signature	Date

Name and Title (Print)

CONTACT INFORMATION

Table of Contents

DATA AND SAFETY MONITORING PLAN AGREEMENT	2

1.	INTRODUCTION	3

2.	ELECTRONIC DATA CAPTURE SYSTEM (EDCS) AND THE DATABASE	3

3.	NETWORK DIRECTORIES	3

4.	DATA VALIDATION PROCESS	3

5.	EDCS SETUP AND IMPLEMENTATION VERIFICATION	3

6.	DATA ENTRY AND CLEANING	3

7.	ELECTRONIC FILE INTEGRATION	3

8.	MEDICAL CODING	3

9.	EDCS EXPORTED DATABASE	3

10.	REPORTS	3

11.	SEVERE ADVERSE EVENTS RECONCILIATION	3

12.	CHANGES TO PRODUCTION EDCS	3

13.	DATABASE CLOSURE	3

14.	DATA ARCHIVING	3

Introduction

Describe the study, clinical trial phase, and protocol design components not evidenced in the protocol title. Describe the purpose of this clinical data management plan (CDMP). Include its role in informing stakeholders and in handling data safely and appropriately. Ensure that there will be a high-quality database at the conclusion of the project. Also, describe how this document will be reviewed, approved, and modified during the project and what SOPs govern its modification and use.

Electronic Data Capture System (EDCS) and the Database

Describe the EDCS that will be used for this study. Also, describe the version number and the validation status. Describe the information security, disaster response plan, audit trail, and electronic signature capabilities. Describe other software related to the EDCS and the server used for this software.

Network Directories

Describe the network directories for this project as well as their security, disaster recovery plan, and structure.

Data Validation Process

Describe the edit check portion of the EDCS, including:

•	Univariate alerts

•	Multivariate and cross-module alerts

EDCS Setup and Implementation Verification

Describe the procedures and documents to implement the EDCS, including:

System specifications

User acceptance testing

Data Entry and Cleaning

Describe the following:

SITE DATA ENTRY TRAINING
ACCESSES FOR EDCS
DATA ENTRY AND DATA ENTRY COMPLETION GUIDELINES
DATA SECURITY
QUALITY CONTROL PROCEDURES
QUERY GENERATION, INCLUDING AUTOMATIC (EDCS-GENERATED) AND MANUAL QUERIES

Electronic File Integration

Describe how and when electronic files that are not generated in the EDCS will be loaded and integrated into the EDCS. Detail the security precautions and verification procedures.

DATA TYPE	DATA FORMAT/SOURCE	TRANSFER FREQUENCY/LOCATION	CUMULATIVE OR NEW?	ADDITIONAL INSTRUCTIONS, if necessary
Hematology	.xls/Site 2 lab	Weekly/Secure FTP	New	Store in F:/HemaData/FromSite2. If errors occur, send email to data manager and IT expert.

Additionally, describe the process for receiving and using lab-issued normal-range data.

Medical Coding

Describe the tools, methods, and conventions for medical coding, where necessary. Specify the coding dictionary and version, if necessary. Describe the periods of review required for medical coding and the procedure for the final medical coding review. Also, include the following:

•	Adverse event and medical history coding

•	Medication coding

EDCS Exported Database

Describe the EDCS export frequency, scope, and format, if necessary.

Reports

Describe the reports to be generated for this study in the table below.

REPORT NAME	PURPOSE	FREQUENCY	RECIPIENTS	HOW DELIVERED

Severe Adverse Events Reconciliation

Describe in the space below how the safety and clinical databases will be reconciled. Also, list the fields to be compared and the procedures for handling discrepancies.

Changes to Production EDCS

Describe the process of proposing, reviewing, and documenting changes to the EDCS. Also, describe what testing needs to be performed and documented to accept the changes.

Database Closure

Describe all processes associated with database closure, including:

•	Closure checks

•	Quality assurance audit and database lock

•	Database unlock

Data Archiving

Describe the scope, format, and process to deliver final electronic data that will not be stored in the EDCS. Also, describe the plan for delivery of any Public Use data, as required.

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