Clinical Data Management: A Complete Guide

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 Course Description:  

First Pharma allows you as a student to apply the theoretical knowledge and skills gained during the mentioned course in an effective manner in the clinical research industry. CDM is involved in all aspects of processing the Clinical data, working with a range of, database systems (Oracle Clinical, medidata Rave, Oracle inform, Veeva, etc..) computer applications to support the entire network in it. The responsibility of clinical data management goes starting from clinical data tracking from locking it and archiving it. All modules cover the principles and practices required to ensure that the patient data collected as part of a clinical trial are of high quality prior to analysis. The course reviews the stages in the data management project life cycle from project preparation, through CRF review and database creation to data entry, data quality control, and project closeout.

1. Study startup -

Approved Protocol, Project Plan, eCRF Specification, Visit Form Matrix, DB design , UAT, IxRS Integration, Final Sign off – Go Live, DMP

2. Study conduct  & closeout

 Tracking CRF, Data Creating Data Collection Modules and layouts corresponding to CRFs to allow for data entry Entering data, Generating and Testing data entry screens and validate the range, format, date, missing fields Data validation User acceptance testing (UAT) Managing lab data Identifying and Managing discrepancies Collecting AE Data SAE Reconciliation Reviewing clinical data as per SOP, protocol, and study specific guidelines Medical Coding IxRS Reconciliation Listing Reviews, consistency checks QC Status Reports All Subjects completed final visits/f-up visits Medical Coding data review completed and issues resolved Final SAE reconciliation All queries resolved and DB updated Final review completed All expected forms and visits are locked/frozen, QC steps conducted and QC plan and report documented QA issues addressed if any All documentation completed as per DMP and stored according to SOP Data is archived/submitted

3. Process flow –

Data management plan Study set up  Tracking CRF Data Entering data Managing lab data Identifying and Managing discrepancies Collecting adverse Event Data

All the stages should in Compliance with regulatory requirements and International Conference on Harmonization (ICH) Good Clinical Practice (GCP) is emphasized. 

Students will learn how to establish the necessary infrastructure, and how to obtain the necessary skills and resources required to manage a successful data management project.

These modules will cover issues relating to the ongoing monitoring of the data in a study in order that sufficient data are available per protocol to answer the trial’s question reliably without recruiting more patients than necessary or exposing them to unacceptable risks. The module will, therefore, focus on the ethical context of decisions about whether or not to continue entering

CERTIFICATION IN CLINICAL DATA MANAGEMENT

Customized industrial training is available for Fresher’s and experienced.

Our exclusive program for Freshers and experienced with below 2 years of experience helps professional growth comparatively.

Certification from SCDM

1. CCDA – for fresher’s / experienced with below 2 years of experience 

2. CCDM – For experienced with greater than 3 years

Duration: 2 months

Sessions: 3 times a week

Session Duration: 2 hours per session

Total Hours: 48 hours