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CONTRACT TO CONDUCT A POSTMARKETING OBSERVATIONAL STUDY WITHMEDICINAL PRODUCTSTitle: ___ Protocol Code: ___.In ___ on ___ ___ 201_,I. BY AND BETWEEN For one part (Centre) Ms. Itziar Prez Irazusta

How to fill out post-authorisation-study-contract-psc- template

How to fill out post-authorisation-study-contract-psc

1. Identify the study objectives and endpoints that need to be included in the post-authorisation study contract (PSC).
2. Determine the study design, including sample size, study duration, and methodology.
3. Identify and select suitable study sites and investigators.
4. Define the roles and responsibilities of all parties involved in the study, including the sponsor, investigators, and study staff.
5. Negotiate and finalize the contract terms, including budget, payment terms, and deliverables.
6. Obtain any necessary ethical and regulatory approvals before commencing the study.
7. Monitor the study progress and ensure compliance with the contract terms throughout the study period.
8. Analyze the study data and prepare a final study report for submission to regulatory authorities.

Who needs post-authorisation-study-contract-psc?

1. Pharmaceutical companies conducting post-authorization studies for their products to fulfill regulatory requirements.
2. Contract research organizations (CROs) hired to manage and conduct post-authorization studies on behalf of pharmaceutical companies.
3. Regulatory authorities requiring post-authorization studies to assess the safety and efficacy of a drug or medical device after it has been approved for marketing.

What is Post-Authorisation-Study-Contract-PSC- ... Form?

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What is post-authorisation-study-contract-psc?

Post-authorisation study contract (PSC) is a mandatory contract between the marketing authorisation holder and regulatory authorities, outlining commitments for conducting post-authorization studies to further evaluate the safety and efficacy of a medicinal product.

Who is required to file post-authorisation-study-contract-psc?

The marketing authorisation holder is required to file the post-authorisation study contract (PSC) with regulatory authorities.

How to fill out post-authorisation-study-contract-psc?

The post-authorisation study contract (PSC) should be filled out according to the specific guidelines provided by regulatory authorities, including details of the proposed post-authorization studies.

What is the purpose of post-authorisation-study-contract-psc?

The purpose of the post-authorisation study contract (PSC) is to ensure that the marketing authorisation holder fulfills its obligations to conduct necessary post-authorization studies to monitor the safety and efficacy of the medicinal product.

What information must be reported on post-authorisation-study-contract-psc?

The post-authorisation study contract (PSC) must include details of the proposed post-authorization studies, timelines, milestones, and any amendments to the original agreement.