Get Instructions To Complete The Clinical Trial Submission Form - Cancer Osu

Completing the Clinical Trial Submission Form for cancer-related protocols is a critical step in initiating research projects. This guide will provide a comprehensive overview of each section of the form to ensure a smooth submission process.

Follow the steps to effectively complete the form online.

1. Press the ‘Get Form’ button to access the submission form and open it in the online editor.
2. On Page 1, enter the Title from your protocol in the designated area. Leave the Protocol Number blank unless you are working with a cooperative group trial.
3. Complete the PI Name section by providing the name, phone number, and email address of the principal investigator.
4. If applicable, add the Co-PI information, noting that additional co-PIs can be included on a separate sheet.
5. Fill in the Emergency Contact section with the details of a trial manager, clinical research coordinator, or regulatory officer, ensuring it is not the PI.
6. Indicate the Phase of Study, usually found in the protocol title. If it is an investigator-initiated trial, mark 'Pilot study' if no phase is stated.
7. Answer whether the PI authored the protocol by selecting 'Yes' if it is an investigator-initiated study.
8. Select the type of Sponsor, indicating if it is Investigator Initiated or other options such as NCCN.
9. Choose the Scope by marking Local for OSU only or National for multiple sites.
10. Specify the Type of Study under the Non-Therapeutic section, detailing the relevant type of study.
11. Determine if the protocol involves the transfer of recombinant DNA or RNA and respond accordingly.
12. Indicate whether the protocol involves live, recombinant, or attenuated microorganisms.
13. On Page 2, provide Total Protocol Target Accrual details for multi-site trials and set an appropriate Total Accrual Goal with upper and lower limits.
14. Specify the Accrual Duration in months, denoting how long the trial will be open to accrual.
15. Estimate the Screen Failure Rate, indicating the anticipated percentage of patients who will be deemed ineligible after consent.
16. Select the Disease Specific Research Group and CCC Program area for categorizing the protocol.
17. On Page 3, identify all Institution/Study Site Information that applies, particularly if there are subsites.
18. Ensure the Data and Safety Monitoring text is included for all investigator-initiated trials.
19. If applicable, skip the Resource Utilization section based on specified criteria.
20. Complete the Trial Overlap section if relevant, noting if the protocol competes with any open or pending trials.
21. On Page 6, print the PI name and include the Disease Leader name as required, along with any necessary signatures.
22. Once all sections are completed, save your changes, and proceed to download, print, or share the form as needed.

Complete your Clinical Trial Submission Form online to advance your research efforts.