Short Study Title

SHORT STUDY TITLE

Long Study Title

TRIAL DATABASE:

Requirements and Specification

CONTENTS

1.Background

2.Purpose

3.Data Base Requirements

3.1 Data

3.2 Queries

3.3 Reports

3.4 Export For Analysis

3.5 Maintenance

3.6 Storage And Security

3.7 Audit

3.8 Archive

4.Database Construction

4.1.Program

4.2.Design

4.3.Building

4.4.User Acceptance Testing

4.5.Approval

Appendix A

ABBREVIATIONS

BACKGROUND

The SHORT STUDY TITLE requires a trial specific database for the storage of all data collected.

In SHORT STUDY TITLEX patients are being enrolled to receive insert details of intervention. Approximately, Xpatients will be screened to recruit X. The following data is being collected:

• Patient initials and date of birth
• Demographic data (race, sex etc)
• Screening data to confirm eligibility
• Blood results
• Vital signs
• Insert any other study specific data collected (imaging, ECGs, pregnancy test, virology, dose administration, QoL etc)
• Adverse Events (AEs)
• Serious Adverse Events (SAEs)
• Concomitant Medications
• End of study data (date, reason for withdrawal etc)

SAEs will be recorded and stored in the CECM Pharmacovigilance Database. All other data will be collected in a study specific database.

The database will be locked at these time-points during the study:

• Insert details of interim analysis
• At end of study within X days of receipt of last CRF page for last study patient

At these time-points the database will be transferred to an appropriate statistical software package for analysis.

No identifiable patient information is being collected as part of this study.

Or,

The following patient information is being collected as part of this study:

• Insert details i.e. hospital number, full name, address etc

This information will/will not be stored in the trial database.

This database will be designed and maintained in compliance with JRO SOP 38 Trial Management systems.

1. PURPOSE

This document describes the requirements from which theSHORT STUDY TITLEdatabase was designed and the User Acceptance Testing (UAT)

1. DATA BASE REQUIREMENTS

The following are requirements for the SHORT STUDY TITLE database:

• The database must hold all data collected in the CRFs

• The database should allow for straight forward data entry

• The database should be able to have mandatory and non-mandatory fields

• A code must be assigned for missing fields

• The database must be able to raise automatic queries for the following fields:
• Dates
• Out of range values
• Insert any trial specific automatic queries (i.e.: entering a male onto a cervical cancer study.....)

• It must be possible to raise manual queries in the database

• The database must flag missing fields

• The database must be able to run reports as appropriate

• No analysis needs to be performed within the database. However, the database must be able to transfer data to an appropriate statistical software for analysis at required time points throughout the study

• An appropriately trained individual must be identified to maintain the database, including:

• Rectifying problems
• Updating the database as appropriate (i.e.: with CRF amendments etc)
• Providing training to new users of the database

• The database and its outputs must be kept on a secure server

• The database and its outputs must have restricted access

• The database must have a ‘log-in’ function

• The database must be able to identify who has entered the data

• The database must be able to indentify the time and date an activity was performed

• The database must be able to show if any changes are made, including who made a change and the date and time the change was made

• The database and its outputs must be archived at the end of the trial as an electronic file in a format that can be accessed for a minimum of 20 years as per Sponsor policy

• The datamust be archived at the end of the study at a minimum as a paper document with the Trial Master File for a minimum of 20 years as per Sponsor policy.

1. DATABASE CONSTRUCTION

4.1.Program

Insert Program and version to be used

4.2.Design

Database design has been agreed with the Chief Investigator and Trial Statistician, based on version X of the CRFs.

The following study specific pages will be utilised:

If data is missing, and will never be obtained, XX will be used to identify this.

4.3.Building

Building the database is the responsibility of the Clinical Trial Coordinator (CTC), as delegated by the Chief Investigator.

The Insert role of person building database has been appropriately trained to build the database, by attending course name or description. Record of attendance on this course can be found in the Insert role of person building databases training file.

4.4.User Acceptance Testing

Persons:

User Acceptance Testing (UAT) will be performed by the Research team, who are suitably experienced and trained, one of whom will not hold authorisation access (unauthorised user).

Process:

Testing Scripts will be devised to perform UAT. These will be devised after the database has been built. Copies of these will be available in the TMF.

Documentation:

The process of UAT will be fully documented on the testing scripts.

The individuals involved in UAT will collate their results to produce one report summarising the outcomes of UAT on the database.

4.5.Approval

Results and evidence of UAT will be provided to the Principal Investigator or designate team memberwho will evaluate if all requirements have been successfully met.

Approval will only be given if all requirements have been met, or rationale provided if any requirement is not met.

Approval will be documented using the approval form (appendix A). This will be countersigned by CI.

All documentation will be filed in the Trial Master File.

APPENDIX A

Study - Database;Version 1.0 dated XX Page 1 of 7