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How to Move Page Clinical Trial Agreement

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today we are very fortunate having uh michael slocum join us he is the senior member of the law firm sloka momboti specializing in contract law legal issues related to clinical applied and basic research corporate issues intellectual property and executive estate planning he has more than 40 years of experience and has represented hospital systems hundreds of businesses both in the us and in foreign countries universities nonprofit organizations and even agencies of the federal government mr slocum negotiates clinical trials and other research contract terms with drug companies and other entities on a daily basis mr slocum began began private practice with his own law firm in 1980 he is an honor graduate of the depauw university and received his jd with honors from george washington university national law center he is a member of the virginia state law bar he is a distinguished faculty member of the society of research administrators and an adjunct professor and graduate school of nu

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What are the parts of a clinical trial agreement?

A clinical trials agreement should describe and acknowledge responsibilities, terms of collaboration, requirements for payment and reimbursement, publication and intellectual property terms, indemnification and or insurance, subject injury coverage, guidelines for dispute resolution, grounds for termination of contract

What is the difference between a CTA and CDA?

1:43 4:08 cta vs cda in clinical research what is the difference? - YouTube YouTube Start of suggested clip End of suggested clip CDA so they sound alike if youre not careful or if you say it fast. They sound like theyre theMoreCDA so they sound alike if youre not careful or if you say it fast. They sound like theyre the same thing right. Well theyre different so the CTA is a clinical trial agreement. It is a contract.

What is a clinical trial site agreement?

The contract of Clinical Trial Agreement (CTA) is a legally valid document that manages the relationship between the body that is providing the study drug or device, the financial support and /or proprietary information and the institution that is providing data and/or results, and publication.

What are the components of a clinical trial agreement?

A clinical trials agreement should describe and acknowledge responsibilities, terms of collaboration, requirements for payment and reimbursement, publication and intellectual property terms, indemnification and or insurance, subject injury coverage, guidelines for dispute resolution, grounds for termination of contract

What is the major issue in clinical trials?

Patient recruitment, including patient retention and population diversity, tops the list of challenges that 55% of respondents face. One respondent shared that clinical studies are becoming larger, longer and more complex, leading to increased competition for study centers and individual patients.

What is the major legal agreement in clinical trials?

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 are the main laws and regulations that govern clinical trials conducted in the USA?

All clinical trials conducted to secure FDA marketing authorization must adhere to 21 C.F.R. Parts 50 and 56 which are regulations designed to protect the rights of human subjects. Part 50 governs the requirement for securing informed consent from human subjects who participate in clinical trials.

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.

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