Easily Hide Advanced Field into the Clinical Trial Agreement

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How to Hide Advanced Field into the Clinical Trial Agreement

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well good afternoon everyone im david glaser and im just here to do a quick introductions and announcements uh and well turn it over to uh bob and katherine in a moment so our webinar our next webinar is on august 12th and the topic is going to be lessons from recent data bdocHubes and there have been some expensive lessons lots of seven figure lessons so this theyre going to talk about hipaa and otherwise katie ilton briar andreessen and lad will be doing it and theyre going to be talking so youre going to want to get your privacy and security people in on this so this is things like um you know uh how do you when you do it with how do you hire a vendor if theres been a data bdocHub what due diligence should you do on vendors to try to prevent data bdocHubes tips for dealing with bit data bdocHubes tips for dealing with the ocr on audits and settlement and having a good security policy so thats on august 12th same time a couple quick news announcements some of you may have heard a

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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 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 CTA in a clinical trial?

Definition. A clinical trial agreement (CTA) or clinical study agreement (CSA) is a legally binding agreement that governs the conduct of a particular study and sets forth the obligations of each party to the agreement.

What is a CTA agreement?

Contractor Team Arrangement Agreement means the written agreement between team members detailing the responsibilities of the team and each team member. Team Leader means the contractor who has been designated as the leader and whose responsibilities have been outlined in the CTA Agreement.

What is excluded from clinical trials?

Exclusion criteria specify characteristics that disqualify patients from participation and often include factors such as comorbidities or concomitant treatment or factors that could mask the effect of the intervention.

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 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.

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Hide Advanced Field into the Clinical Trial Agreement