Q1: How do I submit a new contract?
Starting from October 1, 2024, please prepare the IRB number, Taipei Medical University Clinical Trial Budget Form, Clinical Trial Agreement, and Contract Checklist, and submit the documents through the university’s Clinical Trial Contract Review System.
Q2: Can the review of the Clinical Trial Agreement be conducted simultaneously with the Ethics Committee’s review of the protocol?
Yes, as long as you have obtained the IRB number, you can submit the contract simultaneously. Please prepare the necessary documents and submit them through the system.
Q3: How long does the administrative review of the contract take?
The administrative review generally takes about 5 business days, but this may vary depending on the volume of submissions.
Q4: When should the contract review fee be paid?
Starting from October 1, 2024, the notification for the payment of the contract review fee will be sent after the administrative review is completed. The substantive review will only begin after payment confirmation.
Q5: How long does the contract stamping process take?
If all documents are complete and accurate, the contract stamping process takes approximately 10-12 business days.
Q6: How should contracts involving multiple affiliated hospitals be signed?
Please consolidate the signatures of all parties onto the same signature page of the contract.
Q7: What is the process for the principal investigator’s signature after the contract is finalized?
The sponsor should first send the contract to the principal investigator for signature. Once signed, the contract should be sent back to the center for the subsequent stamping process.
Q8: When can the IRB approval letter for a new contract be obtained?
The IRB approval letter can be downloaded once the contract has been officially signed.
Q9: When can the IRB approval letter for an amendment be obtained?
The sponsor should confirm whether the amendment contract is valid and whether the IRB changes involve adjustments to the contract. If confirmed, download access can be granted within 1-2 business days.
