Good Clinical Practice: A Question and Answer Guide2024/2025 Edition - 271

Clinical Data Management
11.18 Q. In ICH E6 (R3) Draft Section 3.16 Data and Records, what topics are reinforced for Data Management
processes?
A. There are 29 subitems in this section (3.16.1) Data Handling. These include, but are not limited to,
recommendations as follows:
* The sponsor should ensure the integrity and confidentiality of data generated and managed.
* The sponsor should apply quality control to the relevant stages of data handling to ensure that the data are
of sufficient quality to generate reliable results. The sponsor should focus their quality assurance and quality
control activities and data review on critical data, including its relevant metadata.
* The sponsor should pre-specify data to be collected and the method of its collection in the protocol. Where
necessary, additional details, including a data flow diagram, should be contained in a protocol-related
document (e.g., a data management plan).
* The sponsor should ensure that data acquisition tools are fit for purpose and designed to capture the information
required by the protocol. They should be validated and ready for use prior to their required use in the trial.
*
The sponsor should ensure that documented processes are implemented to ensure the data integrity for the
full data life cycle.
11.19 Q. We know that in the previous version of ICH E6 there has always been the statement " Each individual
involved in conducting a trial should be qualified by education, training, and experience to perform his
or her respective task(s). " Is there a particular emphasis on training when using computerized systems
and what should we expect during an audit?
A. When using computerized systems in a clinical trial, the sponsor should:
* have a record of the computerized systems used in a clinical trial. This should include the use, functionality,
interfaces and validation status of each computerized system, and who is responsible for its management
should be described. The record should also include a description of implemented access controls and internal
and external security measures;
* ensure that the requirements for computerized systems deployed by the sponsor (e.g., requirements for
validation, audit trails, user management, backup, disaster recovery and IT security) are addressed and
implemented and that documented procedures and adequate training are in place to ensure the correct
development, maintenance and use of computerized systems in clinical trials. These requirements should be
proportionate to the importance of the computerized system and the data or activities they are expected to
process. Most EDC applications have some training capabilities such as a self-paced on-line training hosted
by the vendor which may generate a certificate of completion. In other situations, the application may not have
this option and it may stand to the sponsor/CRO to conduct the training in the EDC system. These training
sessions may occur during an Investigator meeting or as a web facilitated session. There should be an SOP
which governs the process as well as a description of the documentation of training. Regardless of the type
of training, on-line or web-based sponsor training, these training documents will be part of documentation to
be available to an auditor.
11.20 Q. What does the draft guidance: Electronic Systems, Electronic Records, and Electronic Signatures
in Clinical Investigations Questions and Answers Guidance for Industry (March 2023) recommend
regarding what documentation the sponsor should have in place for electronic systems that fall under
the scope of part 11, and what will be FDA's focus during inspections of the sponsor? "
A. For each clinical investigation protocol, the sponsor should describe the electronic systems (e.g. IRT system,
EDC, eCOA) used to collect clinical investigation data as well as the electronic systems used to create, modify,
maintain, archive, retrieve, or transmit pertinent electronic records. Sponsors should create a diagram that depicts
the flow of data from creation to final storage. Consistent with a risk-based approach to validation, sponsors
should consider (1) the purpose and significance of the record and the criticality of the data, (2) the intended use
of the electronic system, and (3) the nature of the electronic system to determine when documentation or SOPs
addressing the following are appropriate. The following are the processes that require documentation; System
setup, installation, and maintenance; System validation (e.g., validation plans, execution, and reports); UAT
performed by the sponsor or vendor; Change control procedures and change control; System account setup and
271

Good Clinical Practice: A Question and Answer Guide2024/2025 Edition

Table of Contents for the Digital Edition of Good Clinical Practice: A Question and Answer Guide2024/2025 Edition