CLINICAL DATA MANAGEMENT- AN OVERVIEW

Clinical data management (CDM) is a process that involves the collection, cleaning, and management of data from clinical trials. The goal of CDM is to ensure that the data collected in a study is accurate, complete, and consistent, and that it complies with regulatory requirements and industry standards.

CDM involves several key activities, including:

Data collection: This involves collecting data from various sources, such as electronic medical records, case report forms, and laboratory results. The data must be collected in a standardized and consistent manner to ensure that it is reliable and can be used for analysis.

Data cleaning: This involves identifying and resolving errors or inconsistencies in the data. This may involve checking for missing or incomplete data, verifying the accuracy of the data, and resolving any discrepancies or inconsistencies.

Data validation: This involves verifying that the data meets regulatory requirements and industry standards. This includes checking that the data is consistent with the study protocol, that it has been collected and recorded accurately, and that it is complete and reliable.

Data management: This involves storing and managing the data in a secure and organized manner. The data must be protected from unauthorized access or disclosure and must be available for analysis and reporting.

Effective CDM is critical for ensuring the validity and reliability of clinical trial data. It helps to ensure that the data collected is accurate, complete, and consistent, which ultimately leads to more reliable study results. Additionally, effective CDM helps to ensure compliance with regulatory requirements and industry standards, which is essential for gaining regulatory approval for new medical interventions.

1. Welcome CLINICAL DATA MANAGEMENT- AN OVERVIEW Vanamula Shivani B. Pharmacy CSRPL_STD_IND_HYD_ONL/CLS_009/012023 2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 1

2. Index Clinical Data Management Objectives of CDM What clinical data manager do? Overview Study start up process 2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 2

3. CLINICAL DATA MANAGEMENT(CDM) 2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 3 Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management ensures collection, integration and availability of data at appropriate quality and cost. CDM i s the process of collecting and managing research data in accordance with regulatory standards to obtain quality information that is complete and error-free. The goal is to gather as much such data for analysis as possible that adheres to federal, state, and local regulations.

4. OBJECTIVES OF CDM DATA COLLECTION : Paper, Electonic and Remote data capture DATA INTEGRATION : Integration of data received from all sources in a single DB. Ensures consistency and correctness SYSTEM / DATA VALIDATION System validation done via UAT, QC, and programming data validation via Edit check programs and manual review 2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 4

5. What Clinical Data Manager Do? . www.clinosol.com | follow us on social media @clinosolresearch 5 Approved Protocol Investigator Selection Approval Process Statistical Analysis Data Entered and Reviewed Patient Recruitment presentation and Publication Report Data Field & Registration obtained

6. What Clinical Data Manager Do? . www.clinosol.com | follow us on social media @clinosolresearch 6 A clinical data manager typically has a wide range of responsibilities, which can include: Coordinating with the clinical research team to ensure the integrity of data throughout trials, including monitoring study progress, resolving conflicts, and communicating with investigators Coordinating with IT staff to ensure that data collection tools are compatible with existing systems Reviewing study protocols and ensuring they meet regulatory standards, as well as checking study results for accuracy and completeness Develop and execute SOPs, departmental guidelines and data standards to guarantee database quality control and data management compliance. Document, verify, validate and execute regulatory compliant programs to perform clinical data management activities. Develop requirements of edit checks to guarantee high data quality and develop reports

7. Data validation Data Flow 2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 7 Protocol design DMP design CRF design Database design Data validation Databaselock Statistical analysis Publication Data Capture Reporting

8. STUDY START UP PROCESS 2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 8 Protocol Activated database ready to accept production data Validation/ Derivation Procedures Database Design CRF Design

9. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] 2/10/2023 www.clinosol.com | follow us on social media @clinosolresearch 9