The superseded documents of final documents should always be included in the TMF as they help to reconstruct the trial. Pertinent correspondence that reconstructs the activities and decisions that were carried out during the clinical trial need to be included in the TMF. This includes:. The TMF may contain sensitive information which could unintentionally harm the clinical trial unblind personnel who need to remain blinded throughout the trial.
The storage for the TMF includes paper and electronic server rooms and media archive. They need to protect the documents and keep them eligible.
The storage facilities need to be secure with environmental controls and protection from physical damage. The security, location, environmental risk factors and size should all be assessed before storing the TMF.
Electronic TMFs should allow for appropriate security and reliability, ensuring that no documents are lost or corrupted. According to the ICH Good Clinical Practice GCP guidelines, the copies of the eTMF which replace the original documents should be certified copies of the original verified by date and signature or created through certain processes which allows an exact copy to be produced.
Quality checks of certified copies need to be carried out before the destruction of the original documents, including:. Paper documents may need to be digitised into eTMFs and electronic archiving. This process should be validated so that no important information is lost or changed. A paper copy of an electronic document can be destroyed as long as the original document has already been filed in the TMF.
The documents in the TMF need to be archived so that it is available and easily accessible. This includes the audit trail which should be archived properly so supervision can continue after the clinical trial has been completed. Access to the archived data should be maintained so that data can be accessed in its original form, or so it can be migrated to a new format. Transfer to another media form may be needed in case the storage starts to deteriorate. Before transferring any documents, validation needs to take place to ensure that the migrated data has the same information as the original data.
If the external storage has multiple sites, the exact location of the TMF needs to be known at all times. The Sponsor determines which requirements apply to each clinical trial about to begin, the end dates and whether the trial is used, or intended to be used. It is a way of digitally capturing, managing, sharing and storing those essential documents and content from a clinical trial. Every organization, typically a pharmaceutical company or a biotech company, involved in a regulated clinical trial must comply with government regulatory requirements surrounding those clinical trials.
One of the key criteria to fulfill regulatory compliance is to maintain and store certain essential documents related to that clinical trial. Essentially, a Trial Master File is a set of essential documents and content that shows how a clinical trial was conducted, managed and followed regulatory requirements.
These essential documents allow for the evaluation of the conduct and quality of the clinical trial. In order to comply with government regulatory requirements pertinent to clinical trials, every organization involved in clinical trials must maintain and store certain documents, images and content related to the clinical trial. Depending on the regulatory jurisdiction, this information may be stored in the trial master file or TMF.
It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies. It is a collection of all essential documents pertaining to the trial, which in turn will allow for effective monitoring and supervision audit. According to the GCP guidelines, it is the responsibility of the sponsor to ensure that the TMF includes all relevant essential documents, and is stored in a secure location, with restricted access.
The ISF will also include all site-specific essential documents. For example, site preparedness log or site visit logs, etc. One further point is to ensure data and documents are held in such a way as to ensure their integrity and readability over the length of the study and archival period.
The document also addresses archiving of the TMF, clarifying retention times, in particular expectations in case of digitization and consecutive destruction of paper documentation. This information can then be used in designing your TMF the same principles exist both for hard copy and digital documents in an eTMF.
You will also need to think about security controlled access for hard copy, password protection for an eTMF , definition of original records e. Given the complexities of setting up and maintain a TMF, appropriately training is considered critical. This includes ensuring staff understand the importance of routinely keeping the TMF up to date and not waiting for the announcement of an audit!
It therefore helps to have well-structured procedures and processes in place that promote the collaborative exchange of study records between the CRO, the Investigational sites and sponsor study teams, to ensure that the TMF is complete and accurate. All our resources. Introduction At the beginning of , COVID pandemic hit the whole world and led to unprecedented measures, including general lockdown…. This website uses cookies so that we can provide you with the best user experience possible.
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