Data Management Plan in Clinical Trials.pptx

A Data Management Plan (DMP) describes data that will be acquired or produced during research; how the data will be managed, described, and stored, what standards you will use, and how data will be handled and protected during and after the completion of the project.
What are the steps involved in clinical data management?
Clinical Data Management (CDM) is a critical phase in clinical research which results in collection of reliable, high-quality and statistically sound data. It consists of three phases i.e. start up, conduct and close out.
The CDM team first creates a Case Report Form (CRF), which is the first step in translating generated protocol activities. These information fields must have a clear definition and must be consistent throughout.
Clinical trial is intended to find answers to the research question by means of generating data for proving or disproving a hypothesis. The quality of data generated plays an important role in the outcome of the study. Often research students ask the question, “what is Clinical Data Management (CDM) and what is its significance?” Clinical data management is a relevant and important part of a clinical trial. All researchers try their hands on CDM activities during their research work, knowingly or unknowingly. Without identifying the technical phases, we undertake some of the processes involved in CDM during our research work.
CDM is the process of collection, cleaning, and management of subject data in compliance with regulatory standards. The primary objective of CDM processes is to provide high-quality data by keeping the number of errors and missing data as low as possible and gather maximum data for analysis.[1] To meet this objective, best practices are adopted to ensure that data are complete, reliable, and processed correctly. This has been facilitated by the use of software applications that maintain an audit trail and provide easy identification and resolution of data discrepancies. Sophisticated innovations[2] have enabled CDM to handle large trials and ensure the data quality even in complex trials.
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1. Presented by – D r . geetu Mohan, vinay Kasare& Gayatri Tikar DATA management plan www.siroinstitute.com SIRO Clinical Research Institute

2. Content What is DMP Purpose Roles Involved Benefits Creation and finalization Components Milestones References 2 www.siroinstitute.com SIRO Clinical Research Institute

3. what is dmp What is Data Management Plan? A Data Management Plan or DMP is a formal document that outlines how data are to be handled both during and after the clinical trial is completed. DMP describes the activities to be conducted in the course of processing data. Before the study goes live, all clinical studies should have DMP in place. 3 www.siroinstitute.com SIRO Clinical Research Institute

4. process flow Study is awarded to CRO Kick off meeting CDM Team is selected Prepare first draft of DMP 4 www.siroinstitute.com SIRO Clinical Research Institute

5. Purpose To define procedures, timelines, responsibility, and documentation of clinical data management for the study. To promote consistent, efficient, and effective clinical data management activities for the study. To provide a guide that will ensure compliance with Good Clinical Practice (GCP) Requirements and ensure that the study database is accurate, secure, reliable, and Ready for analysis. 5 www.siroinstitute.com SIRO Clinical Research Institute

6. Roles invoved Medical writer Sponsor representative Study statisticin Data manager Project manager Standalone studies: For standalone studies, responsible role will be as per the scope. 6 www.siroinstitute.com SIRO Clinical Research Institute

7. benefits Serves as a document which will be helpful in proper planning, training, communication and execution of data management activities Ensures compliance with good clinical data management practices throughout the trial and thus assures production of quality data during trial Makes personnel involved in data management activities aware about their respective roles and responsibilities which enhance the smoothness of process Maintains a record of data handling activities by different individuals during study Provides continuity for data management activities when personnel in data management team changes or study goes on for long duration 7 www.siroinstitute.com SIRO Clinical Research Institute

8. Creation and finalization For each new study, clinical data management (CDM) personnel should compose a detailed DMP based on the protocol, work scope, contract, analysis plans, data flows, case report forms (CRFs), other supporting documents, and data management standards and practices. The entire DMP should be drafted and approved by all responsible parties prior to commencement of the work it describes. The clinical data manager should ensure the DMP is kept current, including proper Version control, and that all parties involved agree with the content. 8 www.siroinstitute.com SIRO Clinical Research Institute

9. Creation and finalization The DMP should be considered a living document throughout the life cycle of a study, capturing any changes impacting data management made to the protocol or processes being used. The DMP must be uniquely identifiable, carry such identification on each page (e.g., study code/title) and be subject to version control. Each version should be documented and include date, author, reason for version change and an individual version identifier. 9 www.siroinstitute.com SIRO Clinical Research Institute

10. Components ( considered while creating DMP) 10 Sr.No . Components 1 Protocol Summary 2 Definitions & Acronyms 3 Points of contact 4 Personnel /Role Identification/Training 5 Timelines 6 Dictionary & Coding Management 7 Frequencies of important documents and activities 8 Data entry process www.siroinstitute.com SIRO Clinical Research Institute

11. Components (considered while creating DMP) 1. Protocol Summary Includes synopsis of study protocol, visit schedule or critical data analysis variables within DMP Gives a broad overview of protocol 2. Definitions & Acronyms Includes list of acronyms that are protocol specific & DMP. Provides definitions of terms that may be misinterpreted/misunderstood. 11 www.siroinstitute.com SIRO Clinical Research Institute

12. Components (considered while creating DMP) 3. Points of Contact Name & contact details of primary & secondary point of contact for every trial. 4. Personal/Role identification/Training: Should specify key personnel with roles & responsibilities OR may refer to external documents OR SOPs OR refer to documents related to project related training requirements 12 www.siroinstitute.com SIRO Clinical Research Institute

13. Components (considered while creating DMP) 5. Timelines Lists expected completion targets for all deliverables . May vary based on study parameters (paper based or EDC based studies) 6. Dictionary & Coding Management: Should indicate with medical coding dictionaries. Eg : MedRA , WHO DD, SNOMED 13 www.siroinstitute.com SIRO Clinical Research Institute

14. Components (considered while creating DMP) 7. Frequencies of important documents & activities: Mention frequencies at which reports & data listings to be shared with sponsor team. Also defines reconciliation frequency that are to be performed during conduct phase. 8. Data entry process: Should maintain type of data entry Should specify data transfer & data tracking process. 14 www.siroinstitute.com SIRO Clinical Research Institute

15. Milestones (Appear on study timeline) 15 www.siroinstitute.com SIRO Clinical Research Institute

16. How to handle changes after go-live? Required changes should be made & shared with internal team for review. Draft DMP should be shared with sponsor after incorporating comments from internal team. Once all concerned members approve the changes, document can be finalized & version will be revised 16 www.siroinstitute.com SIRO Clinical Research Institute

17. references https://www.clinicaltrials.gov/ProvidedDocs/14/NCT01602614/SAP_001.pdf https://scdm.org/wp-content/uploads/2019/12/GCDMP-Data-Management-Plan-2019-Edition.pdf 17 www.siroinstitute.com SIRO Clinical Research Institute

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19. www.siroinstitute.com SIRO Clinical Research Institute 19 Siro Clinical Research Institute