China
Africa
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Designing and Running a Clinical Trial
Published in Trevor F. Cox, Medical Statistics for Cancer Studies, 2022
Documentation has to be being sorted out. There has to be a Trial Master File (TMF), which is kept at the trial coordinating site, e.g at the Clinical Trials Unit, and a copy is kept at each participating site in the Investigator Site File (ISF). The ICH E6(R1) guideline lists the essential documentation that should be stored for the trial.
Standard Operating Procedures (SOPs), Audits and Archives
Published in Ann Raven, Clinical Trials an introduction, 2018
With the increasing emphasis on carefully documenting all trials activities, it is very important that filing and archiving are done well. The secretary or office manager should be responsible for creating and maintaining scrupulous files for all the medico-legal documents, correspondence, reports and patient data. Some companies keep these originals together in a Trial Master File. Most trial files will have the following subsections:
The European clinical trials regulation (No 536/2014): changes and challenges
Published in Expert Review of Clinical Pharmacology, 2019
Cristina Scavone, Gabriella di Mauro, Michela Pietropaolo, Roberto Alfano, Liberato Berrino, Francesco Rossi, Carlo Tomino, Annalisa Capuano
Among the new features of the CTR 536/2014, two main aspects could be considered as strictly aimed at or linked to the transparency issue: first, the activation of a single EU portal and database and, second, the requirement to provide summaries of the results of clinical trials in a plain language. Indeed, the main novelty of the CTR is the activation of a single EU portal and database (Clinical Trials Information System – CTIS; Articles 80, 81 of the CTR) at Union level and a single European decision on CTAs (Articles 8, 14, 19, 20, 23). In particular, the new EU portal, which strengthens the already existing EU database, will be used for the submission and maintenance of CTAs and authorizations within the EU [13,14]. Data submitted through the EU portal will be stored in the EU database, which means that the management of CTAs will be centralized, a single EU number will be assigned to each clinical trial, information will be easily accessible in an easy-to-consult format, and data will be continuously updated. This will facilitate the cooperation and communication between sponsors and Member States, but it will also allow EU citizens to access to clinical trial information [15]. Along with the submission of data to the EU portal, the sponsor and the investigator will keep a clinical trial master file (Article 57) that will contain the essential documents of the clinical trial and that will be readily available and accessible to the Member States. The clinical trial master file has to be archived for at least 25 years after the end of the clinical trial.