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How to Upload to Online Storage Clinical Trial Agreement

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um Im excited today to kick off the fall clinical trials toolkit series um our first one is the office of sponsored programs clinical trial agreement review and negotiation um today we have Rachel humberson she is the interim assistant director um from research office and office of sponsored programs and we also have um Julie even though I practiced it Julie Im going to mess it up Anna okay is that right yeah okay she is a negotiator with research with the research office and office of sponsored programs um before I read their um their bios and a fun fact about them again we are offering continuing education to WVU employees so if um you would like CES please indicate that and please put your name um an email address in the chat so for attendance purposes um Im trying to think if theres anything else oh if you have a question during this um feel free to put it in the chat well be watching it and um I will stop Rachel and Julie and let them know what your question is and then also

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Below are some common questions from our customers that may provide you with the answer you're looking for. If you can't find an answer to your question, please don't hesitate to reach out to us.

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What documents should be in a TMF?

Documents in an Investigator/Institution TMF are provided by the Sponsor and includes: Documents containing personal data (code lists, source documents and signed consent forms). Clinical Trial Protocol. Investigators Brochure (IB). Procedural manuals.

How long should research records be kept?

Federal regulations require research records to be retained for at least 3 years after the completion of the research (45 CFR 46) and UVA regulations require that data are kept for at least 5 years. Additional standards from your discipline may also be applicable to your data storage plan.

What is the ICH GCP requirement on the storage period of research records?

ICH E6 Section 3.4 states the EC/IRB should retain all relevant records for a period of at least 3 years after completion of a trial and make them available upon request to regulatory authorities.

What documents should be in a TMF?

Documents in an Investigator/Institution TMF are provided by the Sponsor and includes: Documents containing personal data (code lists, source documents and signed consent forms). Clinical Trial Protocol. Investigators Brochure (IB). Procedural manuals.

How long should the TMF be stored?

Recent changes to the European Medicines Agencys (EMA) guidance require that Trial Master File (TMF) data is kept in an accessible and readable format for a minimum period of 25 years.

What is the required archiving period for data generated from clinical analysis?

The EC(s) should archive all documents and records for an amount of a minimum of 5 years once the completion or termination of a trial.

What is Article 57 considering ETMF?

Article 57 states the clinical trial master file shall at all times contain the essential documents relating to that clinical trial. The requirement at all times means that the TMF should be updated, and completed in a timely manner.

In which format should TMFS be archived?

The best solution is to provide content and metadata in the TMF Reference Model Exchange Mechanism (EMS) format.

Who should be responsible for archiving essential documents ing to best practice?

The PI/DI is responsible for archiving research documentation locally. The Sponsor should inform the investigator site in writing when trial materials are no longer required to be retained. Relevant documentation should be archived in ance with the information submitted for ethical approval.

How long to archive clinical trial documents?

How Long Must Essential Documents be Retained? The IECs/IRBs are only required to retain documents for a period of at least 3 years after completion of the trial.

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Transform your daily workflows and Upload to Online Storage Clinical Trial Agreement

Easy instructions on the way to Upload to Online Storage Clinical Trial Agreement

Follow these simple steps to Upload to Online Storage Clinical Trial Agreement using DocHub:

PDF editing simplified with DocHub

Drive efficiency with the DocHub add-on for Google Workspace

How to Upload to Online Storage Clinical Trial Agreement

Got questions?

What documents should be in a TMF?

How long should research records be kept?

What is the ICH GCP requirement on the storage period of research records?

What documents should be in a TMF?

How long should the TMF be stored?

What is the required archiving period for data generated from clinical analysis?

What is Article 57 considering ETMF?

In which format should TMFS be archived?

Who should be responsible for archiving essential documents ing to best practice?

How long to archive clinical trial documents?

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