04_GCDMP.pptx

GCDMP

1. GOOD CLINICAL DATA MANAGEMENT PRACTICE Presented by Dr. Ankita Suman

2. WHAT ARE DATA? Information (facts /figures) An accounting of the study Who Can Collect Data? Investigators Nurses Research team Participant Participant’s family Participant’s own physician

3. Where Are Data? In the source documents What is a Source Document? It is the First Recording     What does it tell?  1. It is the data that document the trial 2. Study was carried out according to protocol Source Documents Original Lab reports  Pathology reports Surgical reports  Physician Progress Notes Nurses Notes Medical Record

4. What Do You Collect? Biographical data Eligibility Study agent given Concurrent therapy Assessments/tests/exams Adverse Events Response according to protocol

5. What is clinical data management? Clinical data management is the process of ensuring that data collected during the course of a clinical trial is : Accurate Complete Logical Consistent Good Clinical Data Management Practice ( GCDMP): the current industry standards for clinical data management that consist of best business practice and acceptable regulatory standards.

6. In all phases of clinical and laboratory information must be collected and converted to digital form for reporting trials. GCDMP is the version no. 4 of The Society of Clinical Data Management (SCDM). GCDMP provides guidance on the accepted practices in CDM that are consistent with regulatory practices. Addressed in 20 chapters, it covers the CDM process by highlighting the minimum standards and best practices. Chapters addresses each aspect of CDM CRF printing Data privacy Laboratory &other external data Measuring data quality.

7. BASIC COMPONENTS OF DATA MANAGEMENT: Receive Entry Verification Coding Locked data base

8. Organization of DM dept Types of DM personnel varies by organization. Data entry specialists Clinical data coordinator Data manager Database manager Programmer CRF designer Coder

9. Managing the Data Set up plan early Plan CRFs to capture all needed data Collect data as it happens Standardize data entry procedures

10. Data Management Tools Case Report Forms Common Data Elements Electronic Data Capture Audits

11. Data Quality Data entry procedures Certification of data entry personnel Edit checks Ongoing quality checks Different personnel QC data entries Correction of errors Data lock

12. Lists of CDM activities Database designing Databases are the clinical software applications. which are built to facilitate the CDM tasks to carry out multiple studies. Study details like objectives, intervals, visits, investigators, sites, and patients are defined in the database and CRF layouts are designed for data entry. Data collection Data collection is done using the CRF that may exist in the form of a paper or an electronic version.

13. CRF tracking The entries made in the CRF will be monitored by the Clinical Research Associate (CRA) for completeness and filled up CRFs are retrieved and handed over to the CDM team. The CDM team will track the retrieved CRFs and maintain their record. CRFs are tracked for missing pages and illegible data manually to assure that the data are not lost.

14. Data entry Data entry takes place according to the guidelines. Applicable only in the case of paper CRF retrieved from the sites. Data validation the process of testing the validity of data in accordance with the protocol specifications. Edit check programs are written to identify the discrepancies in the entered data, which are embedded in the database, to ensure data validity.

15. Discrepancy management This is also called query resolution. Discrepancy management includes reviewing discrepancies, investigating the reason, and resolving them with documentary proof or declaring them as irresolvable. Discrepancy management helps in cleaning the data and gathers enough evidence for the deviations observed in data. Medical coding Medical coding helps in identifying and properly classifying the medical terminologies associated with the clinical trial.

16. Commonly, Medical Dictionary for Regulatory Activities ( MedDRA ) is used for the coding of adverse events as well as other illnesses and World Health Organization–Drug Dictionary Enhanced ( WHO-DDE) is used for coding the medications. Medical coding helps in classifying reported medical terms on the CRF to standard dictionary terms in order to achieve data consistency and avoid unnecessary duplication. Database locking After a proper quality check and assurance, the final data validation is run. If there are no discrepancies, the SAS datasets are finalized in consultation with the statistician. This is done as the database cannot be changed in any manner after locking.