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How to Modify 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

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Got questions?

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How do you keep up to date with clinical trial best practices?

Its impossible to keep up with the rapid pace of medical research.3 tips for staying up to date on current medical practices Attend networking conferences. Read peer-reviewed research. Seek out expert-curated content.

What is a clinical update?

Clinical Updates means material information and developments with respect to each Clinical Trial, including, without limitation, any serious adverse event in any Clinical Trial.

How do you write a contract modification?

Always put a contract amendment in writing and make sure both parties sign and date it. Reference the title of the contract, if applicable; its original parties; and original signing date, so that it is clear what document you are amending. Attach the amendment to the original contract.

Is a clinical trial agreement the same as a contract?

A CTA serves as a legally binding contract between a sponsor, site, and researcher, and outlines each partys responsibilities and obligations for the clinical trial.

How do you update clinical trials?

At any time, you can make updates and edits to a record published on ClinicalTrials.gov by logging into the Login to ClinicalTrials.gov PRS and clicking on Edit Record under the Protocol Records heading on the PRS main menu.

How are clinical trials reviewed?

Institutional review boards. Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of doctors, researchers, and members of the community.

What is limitation of liability in a clinical trial agreement?

At its most basic, a limitation of liability clause is simply a provision that limits the amount and type of damages one party can recover from another. Such limitations can be quantitative, qualitative or both. A quantitative limitation of liability clause caps one partys potential liability to a determinable amount.

How often is ClinicalTrials.gov updated?

Required Updates to a ClinicalTrials.gov Record In general, the Responsible Party must review and update, as necessary, an active study record at least once every 12 months.

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