Clinical Trial Agreement - Office of Human Research

Business

Clinical Trial Agreement

Application

Taipei Medical University Clinical Trial Contract Submission System: https://redcap.tmu.edu.tw/redcap/surveys/?s=MEN4MC9AJDMPNFP9

Important Notes

Starting from October 1, 2024, clinical trials must obtain an IRB number and a budget form signed by representatives from both the executing institution and the sponsor before submitting the contract for review.
After the administrative review is completed, the center will send a notification for the payment of the contract review fee. Please submit the payment upon receiving the notice. The substantive review will only begin after payment confirmation.
Upon receiving the system notification for contract stamping, the sponsor must have the final version of the contract signed by the principal investigator. After the signature is completed, please send the signed contract back to the Taipei Medical University Joint Clinical Research Center (JCRC) for the subsequent stamping process.
After receiving substantive review comments, please respond within 30 calendar days. If no response is received within the deadline, the application will be considered withdrawn, and a new submission and fee payment will be required.

➜ FAQ

Contract Review Fee

Fee for New Contract Review

Notes:

Continued Use: Refers to the use of the sponsor/CRO's template contract for non-first time use. If the contract has been reviewed and stamped by the JCRC within the past 24 months, only the trial-related information (e.g., IRB number, sponsor name, trial site, principal investigator, drug information, budget list , start and end dates, signature and payment agent information) needs to be updated.
Principal Investigator-Initiated Trials: Includes multi-center trials initiated by the principal investigator of TMU and affiliated hospitals, and trials without any funding.
Bilingual Contracts: If the sponsor's template contract is provided in both Chinese and English, the English version will be charged.
Separate Chinese and English Contracts: If the sponsor's template contract is provided in both Chinese and English separately, only the English version will be charged.

Fee for Contract Revision

Effective October 11, 2024, an administrative fee of NT$1,000 will be applied for each revision requested to an existing contract. This includes, but is not limited to:

Adjustments to the budget
Addition of supplementary attachments
Modifications to contractual clauses
Contract extensions
Changes to the company or its authorized representative
Contract transfers

For any inquiries or requests regarding contract revisions beyond what's listed here, please do not hesitate to contact us at contract.jcrc@tmu.edu.tw.

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