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GUIDANCE ON USE OF THE TRIPARTITE
MODEL CLINICAL INVESTIGATION AGREEMENT
FOR MEDICAL TECHNOLOGY
INDUSTRY SPONSORED RESEARCH
IN NHS HOSPITALS
MANAGED BY
CONTRACT RESEARCH Organizations
(CRO CIA, 2014
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How to fill out model clinical investigation agreement
To fill out a model clinical investigation agreement, follow these steps:
01
Review the agreement: Start by carefully reading through the entire agreement to understand its terms and conditions. Pay close attention to any specific instructions or guidelines provided.
02
Gather necessary information: Collect all the relevant information required to complete the agreement. This may include details about the parties involved, the purpose of the clinical investigation, the location, and any specific requirements or provisions.
03
Fill in the blanks: Use the provided spaces or fields in the agreement to enter the requested information. Ensure that the information is accurate and complete.
04
Seek legal advice if necessary: If you have any doubts or concerns about specific clauses or legal terminology in the agreement, it is recommended to consult with a legal professional who specializes in clinical research agreements.
05
Review and revise: Once you have filled out the agreement, carefully review it for any errors, inconsistencies, or missing information. Make necessary revisions before finalizing it.
06
Obtain signatures: The agreement may require signatures from all parties involved, including the sponsor, investigator, and any other relevant individuals. Ensure that all required signatures are obtained.
07
Keep copies: Make copies of the completed and signed agreement for your records. Distribute copies to all relevant parties as needed.
Who needs a model clinical investigation agreement?
A model clinical investigation agreement is typically needed by researchers, investigators, and sponsors involved in clinical trials or other forms of clinical investigations. This agreement helps define the rights, responsibilities, and obligations of each party, ensuring a clear understanding of the terms under which the investigation will be conducted. It provides a legal framework for the collaboration between the sponsor and the investigator, protecting the interests of both parties and safeguarding patient safety during the research process.
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What is model clinical investigation agreement?
The model clinical investigation agreement is a standardized template that outlines the terms and conditions for conducting clinical research studies.
Who is required to file model clinical investigation agreement?
Researchers and sponsors involved in clinical trials are required to file the model clinical investigation agreement.
How to fill out model clinical investigation agreement?
The model clinical investigation agreement can be filled out by entering the required information such as study details, participant information, and legal agreements.
What is the purpose of model clinical investigation agreement?
The purpose of the model clinical investigation agreement is to ensure that all parties involved in the clinical trial understand their rights and responsibilities.
What information must be reported on model clinical investigation agreement?
The model clinical investigation agreement must include details about the study protocol, participant consent, data use, and financial agreements.
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