Role of Clinical Data Management in Clinical Research

Clinical data management (CDM) plays a critical role in clinical research by ensuring the accuracy, completeness, and consistency of clinical trial data. Here are some key roles and responsibilities of CDM in clinical research:

Data collection: CDM is responsible for designing and implementing data collection procedures to ensure that all data is collected in a standardized and consistent manner.

Data quality control: CDM is responsible for implementing quality control procedures to ensure that data is accurate, complete, and consistent across all study sites.

Data cleaning: CDM is responsible for identifying and resolving data discrepancies or errors in the data that may impact the analysis of study results.

Data analysis: CDM is responsible for performing statistical analyses of the data collected in the clinical trial, which are used to evaluate the safety and efficacy of the investigational product.

Database management: CDM is responsible for developing and maintaining the study database, which is used to store and manage all data collected in the clinical trial.

Study documentation: CDM is responsible for ensuring that all study documentation is accurate, complete, and up-to-date, including study protocols, data collection forms, and standard operating procedures.

Compliance with regulatory requirements: CDM is responsible for ensuring that all data collected in the clinical trial is compliant with regulatory requirements and industry standards

1. Welcome ROLE OF CLINICAL DATA MANAGEMENT IN CLINICAL RESEARCH R. Sararaswathi Pharm D Student ID: 056/032023 4/1/2023 www.clinosol.com | follow us on social media @clinosolresearch 1

2. Index Introduction CDM Process Role of CDM in Clinical Research Role of CDM personnel Conclusion 4/1/2023 www.clinosol.com | follow us on social media @clinosolresearch 2

3. INTRODUCTION “Clinical research” is a branch in healthcare science that determines safety and effectiveness of medication, devices, diagnostic products and treatment regimens intended for human use. 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. Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. 4/1/2023 www.clinosol.com | follow us on social media @clinosolresearch 3

4. CDM PROCESS Clinical trials are intended to provide an answer to the research question, so the CDM process is built to deliver data that is reliable, error free and statistically sound. Review and finalization of study documents Database designing Data collection CRF tracking Data entry Data validation Discrepancy management Medical coding Database locking Data extraction and archival 4/1/2023 www.clinosol.com | follow us on social media @clinosolresearch 4

5. Role of CDM in clinical research As a clinical trial is designed to answer the research question, the CDM process is designed to deliver an error-free, valid, and statistically sound database. To meet this objective, the CDM process starts early, even before the finalization of the study protocol. The CDM creates a paper CRF or eCRF. The eCRF approach has lower error rates and a quicker resolution time for discrepancies, it reduces the time required for the drug development process. CDM develops DMP w hich describes the CDM activities to be followed in the trial including all the activities. The DMP is intended to standardize procedures and ensure that all CDM personnel understand the plan.   A Data Validation Manual (DVM) is developed. This document contains the edit check programs for discrepancy identification. 4/1/2023 www.clinosol.com | follow us on social media @clinosolresearch 5

6. Cont … Coding of all medical terms reported allows standardization when it comes time for the data to be analyzed and reviewed. Information on adverse events, medical history, and concomitant medications must be coded in a uniform manner. This is especially important in multicenter trials in which multiple investigators collect and report information. CDM process has a database lock which put in place after all data management activities are complete to ensure there was no manipulation of study data after unmasking of the treatment groups and during the final analysis. CDM process improvement follows a structural process and well-established system for preventing massive financial loss or valuable resources. Data authentication and catalogue process can undergo validation at each stage to avoid irreparable faults. 4/1/2023 www.clinosol.com | follow us on social media @clinosolresearch 6

7. 4/1/2023 www.clinosol.com | follow us on social media @clinosolresearch 7 Role of CDM personnel in clinical research Data manager (project manager): Supervises the entire CDM process Database programmer or designer: Performs the CRF annotations, creates the study database & programmes the edit checks for data validation. Medical coder: facilitate the summarizing and analysis of certain sets of data (e.g., Adverse events, medical history etc.) Clinical data coordinator: supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Quality control associate: verifies the documentation pertaining to the procedures being followed. Checks the accuracy of data entry & conducts data audit.

8. Cont … Data entry associate: Tracks the receipt of CRF pages and performs data entry into the database. Investigators and clinicians: Supervising the proper handling, administration, storage, and destruction of investigational agents. Site and data personnel: tracking the receipt of CRF pages and performs the data entry into the database. Biostatisticians: Advice on study design, calculating the right sample size, and ensure that the enrolled patients are correctly randomized. Medical writers: Prepare the study reports 4/1/2023 www.clinosol.com | follow us on social media @clinosolresearch 8

9. 4/1/2023 www.clinosol.com | follow us on social media @clinosolresearch 9 Conclusion CDM has evolved in response to the ever-increasing demand from pharmaceutical companies to ensure the generation of high-quality data for accurate drug evaluation. To meet these expectations, there is a gradual shift from paper-based to electronic systems of data management. CDM professionals should ensure the standards for improving data quality. CDM, being a speciality in itself, should be evaluated by means of the systems and processes being implemented and the standards being followed.

10. 4/1/2023 www.clinosol.com | follow us on social media @clinosolresearch 10 References Krishnankutty B, Bellary S, Kumar NB, Moodahadu LS. Data management in clinical research: an overview. Indian journal of pharmacology. 2012 Mar;44(2):168. ICBIOCRO. IMPORTANCE OF CLINICAL DATA MANAGEMENT http://www.icbiocro.com/blog/importance-of-clinical-data-management/ 3. Role of Clinical data management system in multi- center clinical trial Jindal A1 , Mishra R1 , Kumari R2 *, Dubey GP3

11. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] 4/1/2023 www.clinosol.com | follow us on social media @clinosolresearch 11