Get Uahs Ria Amendment Application 2020-2025

Filling out the UAHS RIA Amendment Application online is an essential step for researchers looking to amend their ongoing studies. This guide will provide you with clear instructions on how to complete each section of the application effectively and accurately.

Follow the steps to complete the UAHS RIA Amendment Application online

1. Click the ‘Get Form’ button to obtain the UAHS RIA Amendment Application form and open it in your preferred editor.
2. Begin by entering the application submitter contact information. Fill in the last name, first name, phone number, and UA email address in the specified fields.
3. Next, provide the study information. Enter the study UA IRB number, study sponsor name, full protocol study title, sponsor protocol number, current protocol version, and the current protocol date.
4. Indicate whether the study is open to accrual by selecting 'Yes' or 'No'. If applicable, enter the total number of consented subjects, the number of subjects currently on treatment, and the number of subjects on follow-up.
5. If there are no active subjects, please indicate the date the last subject went off study in the appropriate field.
6. Determine if the project sponsor, CRO, or other vendor is based in the EU by selecting 'Yes' or 'No'. Similarly, specify if UA will collect or receive data from subjects in the EU.
7. If data from the EU will be received, indicate whether it will be completely deidentified by selecting 'Yes' or 'No'.
8. In the amendment section, specify the type of amendment (contract, protocol, budget, or informed consent) by checking the appropriate box.
9. If applicable, enter the amendment number, protocol amendment version, and protocol amendment date.
10. Indicate whether the consent forms were revised and, if so, upload the revised consent forms as instructed.
11. If the schedule of events was revised with this protocol amendment, upload the revised schedule of events table for PCA review.
12. If you require data from Cerner, complete and upload the CRDW request form as instructed.
13. Provide any additional comments related to the amendment in the amendment comments section.
14. For contract/budget amendment information, fill in the UA account number, sponsor/CRO negotiator names, phone numbers, and emails as necessary.
15. If there is a current PI change, fill in the new PI details, including name, email, degree, and relevant unit changes.
16. Finally, make sure to attach any required documents, such as budget amendments, consent forms, and protocol amendments, as specified in the document.
17. After you have filled in all relevant sections and attached necessary documents, save your changes, download a copy, and/or print and share the form as needed.

Begin filling out your UAHS RIA Amendment Application online today.