Easily Delete Field Settings into the Clinical Trial Agreement

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How to Delete Field Settings into the 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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What documents are included in 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.

What documents should be in a TMF?

Investigator Brochure (IB) and/or Summary of Product Characteristics and any updates. Certificate of Analysis of IMP(s) Instructions for handling the IMP (if not already in the IB) Treatment allocation and decoding documentation (for blinded trials) Drug delivery/return records (e.g. Shipping documents) Sample labels.

What is included in the eTMF?

The electronic Trial Master File (eTMF) is an application which leverages software and server technology to guide and assist the setup, collection, storage, tracking and archival of essential clinical study documents.

What is a Section 801 clinical trial?

Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) refers to a federal statute established in 2007 requiring the registration and reporting of information on applicable clinical trials on Clinicaltrials.gov.

What are the essential documents to be generated after completion or termination of the clinical trial?

DOCUMENTS NEEDED AFTER COMPLETION OR TERMINATION OF A CLINICAL TRIAL. Following completion of a trial, a comprehensive clinical study report (CSR) must be written that provides a detailed description of the results of the study, whether positive or negative.

What are essential documents in clinical trial?

International Conference on Harmonization (ICH) Good Clinical Practices (GCP) guidance defines essential documents as those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced.

What are the settings of clinical trial?

Clinical trials are conducted in different settings (e.g., community hospitals, academic hospitals, specialty treatment centers) and locations. Trials initiated by the PI may be single or multi-center. Single-center trials are available only at the PIs academic hospital.

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