TEMPLATE DATA MANAGEMENT PLAN

Transcription

1 TEMPLATE DATA MANAGEMENT PLAN ICRIN (QM sub group) Version: XX Date: XXXXXXX Page 1 of 6

2 1.0 Document Ownership The Data Management Plan (DMP) will be initiated and subsequently owned by the Data Manager assigned to the study, who will be responsible for the production, review and maintenance, until study completion. 1.1 Document Author and Approvals Author Name Title Date Authoriser Effective Date: 1.2 Change History Effective Date Author Version Number Significant Changes Superseded Version 2.0 Purpose The purpose of the DMP is to define and provide instruction regarding the data management processes for the clinical study. The activities cited in the DMP reference the site and/or Sponsor standard operating procedures. However if the clinical study has unique data handling requirements due to sample size, visit schedule, type of data collected and/or method of data collection, study specific procedures for managing the clinical study data will be documented. The DMP facilitates the adherence to study procedures and documents: Protocol information Data management processes Responsible individuals Applicable SOPs and guidelines Study documentation to be produced Page 2 of 6

3 3.0 Protocol Information 3.1 Protocol The study protocol describes the objective(s), design, methodology, statistical considerations and the organisation of the study. The study protocol is located in the Trial Master File. 3.2 Protocol Summary Protocol Number: Protocol Title : Protocol Acronym: Protocol Objective : Principal Investigator : Project Team : Phase: Methodology: Study Centres: Study Duration: Diagnosis: Number of subjects: Study agent, Dose, Route, Regimen: Reference Therapy: Duration of Treatment: Duration of Follow Up: 4.0 I.T. Details <The Sponsor protocol number used to identify this study> < Full protocol title> <Shortened protocol acronym, if one is to be typically used> <Brief statement on primary and secondary study objectives> <Name of PI> <Details of project team> <Phase of study> <Design attributes such as single blind, double blind or open label> <Single or multi centre. If multi centre list number of projected centres to be involved. List study centres> <Estimated duration for the main protocol> <Note the main clinical disease area> <Number of subjects projected for entire study> <Study drug name. Also dose, dose route and dose regimen> <Note if there is a standard reference therapy against which the study drug(s) is being compared, or if the reference is a placebo.> <Total duration of treatment administration> <Total duration of follow up or specify if until disease progression, death.> Software : Software Owner : <Name and Version> 5.0 Procedure for Identifying and Recruiting Patients <Please describe the mechanism which will be used to identify and contact study participants, with due regard to data protection requirements for handling of confidential information. Please refer to Site SOPs and policies.> Page 3 of 6

4 5.1 Patient screening 5.2 Patient Registration 5.3 Study Schedule of Events 6.0 Data Capture <The sites participating in the study with a Case Report Form (CRF) to collect the data generated for a study subject in accordance with the protocol. The Principal Investigator at a site is ultimately responsible for ensuring that local research data is stored and handled correctly. The CRF will be subject to audit by the Sponsor or inspection by the regulatory authorities. > Methods of Data Collection: Paper CRF Electronic Transfer Electronic ecrf 7.0 Data Entry Procedure <This section of the DMP should identify the method of data collection and how sites will be provided with the data collection tool for the study. In addition the processes for CRF development and approval will be documented.> If paper then Type of Data Entry: 1. Double entry (one person) 2. Double entry (two persons) 3. Single entry with a second review 4. Single data entry with reading aloud 5. Single data entry with source verification 8.0 Data Protection How Data will be coded: Person responsible for coding : Users with Access to non coded data: Holder of coding link : 9.0 Quality Assurance Plan Audit Trail Checks : Sample Checks Of Page 4 of 6

5 Critical Data : 10.0 Training Plan User Training Activity Date / / / / / / 11.0 Data Management Responsibilities Role Name Institution and tel. no Clinical Laboratory Data <The DMP should indicate how clinical laboratory data will be captured for the study.> 13.0 Safety Data <The DMP should indicate how data relating to Adverse Events (AEs) and Serious Adverse Events (SAEs) will be captured during the study, including who will maintain the safety database for this study. SOPs relating to the SAE reconciliation process should be referenced and/or study specific processes documented.> 14.0 Data Quality <This section of the DMP should detail the quality control procedures such as SOPs, data monitoring and data validation checks implemented for the study to ensure the quality of the data reported in the final Clinical Study Report.> 14.1 Standard Operating Procedures (SOPs) <If study specific SOPs have been developed, ensure these are also referenced throughout the DMP and listed in the appendix.> 14.2 Data Monitoring <Describe the data monitoring plan for the study, stating whether the site is responsible for the data monitoring or if this will be undertaken by the Sponsor or an external organisation.> 14.3 Data Validation 14.4 Data Discrepancy Management 15.0 Data Outputs <This section of the DMP should detail how data is extracted from the DMP.> Page 5 of 6

6 16.0 Database Closure 17.0 Data Transfer 18.0 Back Up and Recovery Procedures 19.0 Data Security 20.0 Data Archiving <The length of time all study data are to be archived should be specified in this section of the DMP.> Page 6 of 6