Medical devices are more and more used within clinical trial operations, especially in the last years with the huge development of digital medical device technologies; in this context, clinical data management became an essential task for efficient clinical operations.
Clinical data management (CDM) consists in the collection and management of research data in accordance with regulatory standards to obtain quality information that is complete and error-free. The management of clinical data is strictly regulated by agencies and competent authorities whereas since the last years huge focus has been given to data security, cybersecurity and data validation.
Clinical Data Management is basically involved in all aspects related to the processing of clinical data, and typically these activities are performed using a broad range of computer system applications, databases for data collection and specific software tools for data cleaning and management of subject data.
What are the main Regulations applicable in the context of Clinical Data Management?
When you are dealing with clinical data management, it is essential to be fully compliant with regulation that ensures three core concepts:
- Patient Safety
- Product Quality
- Data Integrity
If the clinical trials is runned with United States, it is essential to be fully compliant with the so-called 21 CFR part 11, that deals with the requirements related to electronic records and electronic signature. One of the key requirement associated to electronic data management is the so-called audit trail.
In Europe there is a similar regulation that it is named EU GMP Annex XI, and it is the analogues of the FDA 21 CFR part 11, dealing again with the management of electronic records and electronic signature.
The role of Clinical Data Manager
Activities related to Clinical Data Management are typically performed by the Clinical Data Manager.
From practical point of view this consists in a series of activities to be performed before, during and after the conclusion of clinical study.
Among the preparatory activities before the begin of a study, we can include:
- Case report form design and development
- Database build and testing
- Edit checks preparation and testing
As mentioned before, there are as well activities to be performed during the clinical study, for example:
- Data Entry and evaluation of data discrepancies
- Data Review
- Data Transfer
Subsequently, at the conclusion of the study:
- Quality Control
- Database Lock
- Database Transfer.
Audit Trail and Clinical Database Management
As mentioned afore, the audit trail is one of the key characteristic for computer systems used in the clinical data management context. The concept of the audit trail is reported in the 21 CFR part 11 regulation.
Specifically, the text of the regulation is the following:
Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.
Audit trails are required for all systems that record GxP data, thus including clinical data collected according to Good Clinical Practice. Audit trails should be generated independently of the operator and include the local date and time of the actions that alter the record. They cannot overwrite the old data, and they must be stored as long as the record itself is stored.
Th audit trail shall record the following information:
- Date, time and user that created a specific electronic record;
- Date, time and user that modified, deleted and overwritten a a specific electronic record.
Computer System Validation
Computer system validation can be considered in the broad sense a part of the clinical data management.
We have already been talking about computer system validation and the approach that can be used for this type of activity. Based on the good clinical practices, software validation is one of the key requirements related clinical trials; it is in fact of fundamental importance to validate the software applications used for clinical applications, to ensure patient safety and data integrity.
Computer System Validation (CSV) is basically a process used to ensure (and document) that a computer-based system will produce information or data that meets a set of predefined requirements. These requirements can be linked to user requirements as well as regulatory requirements, for example coming from 21 CFR Part 11 regulation or EU GMP Annex XI regulation. If a system meets these requirements, it can be assumed that it is consistently performing in the way it was intended.
QualityMedDev published the first e-book focused on Computer System Validation. This document is based on the GAMP-5 guideline for CSV and covers in depth the main requirements associated to software validation activities. Moreover, the e-book has a strong practical approach by providing specific examples of validation plan and report with an in depth guideline on the contents of software validation documentation.
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