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Assuring Data Integrity in Clinical Research
Course Summary
Pharmaceutical, biotechnology and medical device companies and clinical researchers need to assure regulatory authorities of the reliability of the data that they generate during product development and testing – that is, to demonstrate data integrity. Practices that provide assurance of data integrity in clinical research are required by law and/or established as expectations in regulatory guidance. The data are reviewed in regulatory applications or during regulatory inspections of clinical trial sponsor and investigational sites. Inadequacies of data integrity are frequently reported by inspectors and result in regulatory actions against the organizations or individuals concerned.
This course explains the requirements and describes principles and practices that should be followed by trial sponsors, investigators and other clinical research personnel to assure regulators of data integrity.
Purchasing Information
When you have completed your course order, Zenosis will finalise the setup of your course materials and contact you on the email address that you provide in your order. You can expect this process to be completed within one business day (using the UK business calendar) of completing your payment.
It is therefore essential that you use your real email address for your order, or indicate in the purchase notes the email address to be used for the course set-up, and check that any messages from Zenosis or grapl are not lost in your junk or spam folder.
You will have access to the course module(s) for a period of 180 days after your purchase is complete.
Detailed Course Information
Learning Objectives
• Describe basic principles of data integrity assurance
• Comply with regulatory requirements and good practices for the assurance of paper-based data in clinical research
• Comply with regulatory requirements and good practices for the assurance of electronic data in clinical research
Who will benefit from this course
This module provides essential learning for all healthcare professionals participating in clinical research, and all clinical development staff of medicinal products and medical device manufacturers
Module Outline
•Data integrity definitions and fundamentals
What do we mean by data?; What is data integrity?; ALCOA, ALCOA+ and ALCOA++; Source data and metadata; Transcription and transformation of data; Static and dynamic data; Certified copies; Archiving and retention; Validation of computerized systems; Data governance; Safeguarding of blinding; Regulators’ responses to data integrity failings
•Integrity of paper-based data
Document control; Recording data by hand; Correcting handwritten data; Submitting paper CRFs to sponsor; Storage, archiving and retention of paper records
•Integrity of electronic data
Electronic source data and originators; Entry of data to an eCRF; Calibration of instruments; Remote data acquisition; Restrictions on access to computerized systems; Manual data entry; Verification of data; Audit trails and other metadata; Modifications and corrections; Review and sign-off of data; Protection of data; Storage, backup and archiving; Data transfer and migration; Electronic signatures
Roles
Healthcare professionals participating in clinical research; clinical development staff of medicinal products and medical device manufacturers
CPD Points
to be confirmed (1)
Region
Level
Introductory
Course Study Time
1 hour
Europe, USA, other