Get Transcelerate Site Profile Form - Transcelerate Biopharma Inc.

Filling out the Transcelerate Site Profile Form is essential for capturing site capabilities during the qualification process. This guide provides clear, step-by-step instructions to help you complete the form online efficiently.

Follow the steps to complete the Transcelerate Site Profile Form online.

1. Press the ‘Get Form’ button to obtain the form and open it in your document editor.
2. Begin by filling out the 'Completed by' section. Include your full name, date completed, role, and the investigator's name as required.
3. In the 'Site Detail' section, provide the institution's name, complete address including city, state, country, and postal code. Select the type of institution and describe its therapeutic capabilities.
4. Indicate whether your site has affiliated research or satellite sites. Detail your research experience with different sponsor types and provide demographics about your patient population.
5. Complete the 'Ethical Committee Review Process' section as applicable. If your site performs ethics committee submissions, provide the required information including the committee's name, location, and registration number.
6. Answer the questions in the 'Informed Consent' section regarding your site's policy for informed consent and any language requirements for translations.
7. Fill out 'Site Qualifications/Training' to indicate whether your site has a training program, covers Good Clinical Practice (GCP), and any external training programs utilized.
8. In the 'Facilities and Equipment' section, detail the local laboratory information, equipment capabilities, and ensure to provide information on temperature monitoring and record-keeping.
9. Provide details in the 'Investigational Product (IP)' section about the shipping address and whether the storage location matches this address.
10. Complete sections regarding the documentation of investigational product destruction, controlled substances, and source documentation.
11. Finally, review your entries for accuracy, then save changes, and choose to download, print, or share your completed form as necessary.

Ready to streamline your document management? Complete your Transcelerate Site Profile Form online today.