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Get Uahs Ria Amendment Application 2019
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How to fill out the UAHS RIA Amendment Application online
This guide provides step-by-step instructions for completing the UAHS RIA Amendment Application online. By following these procedures, you can ensure a smooth filing process while accurately providing the necessary information.
Follow the steps to successfully complete the UAHS RIA Amendment Application.
- Press the ‘Get Form’ button to access the UAHS RIA Amendment Application and load it into the editing interface.
- Begin by filling in your user information, including your last name, first name, phone number, and UA email address. Ensure all personal details are correct to avoid delays.
- In the study information section, enter the study UA IRB number, study sponsor, full protocol study title, sponsor protocol number, current protocol version, and current protocol date.
- Indicate whether the study is open to accrual by selecting 'Yes' or 'No.' Additionally, provide the number of active subjects and the total number of consented subjects to date.
- Answer the questions regarding data collection and transmission in the EU by selecting 'Yes' or 'No' where applicable, and provide information on whether the data will be completely deidentified, if relevant.
- Specify the type of amendment by checking the relevant boxes including Contract, Protocol, Budget, or Informed Consent Form. Provide amendment numbers and relevant details as necessary.
- If the informed consent form has been revised, upload the updated document as prompted. Repeat this for any changes to the schedule of events using the designated upload feature.
- Complete the contract and budget amendment information by inputting the UA account number and providing contact details for the sponsor or contract negotiator.
- If there is a change in the principal investigator (PI), ensure that you fill out the necessary fields for the new PI's name, degree, UA email, and employer, along with additional questions regarding the PI's change.
- Attach any required documents as indicated in the final section. This may include the budget amendment, revised consent forms, and any correspondence related to the amendment.
- Once you have completed all sections and verified the information, proceed to save your changes. You can download, print, or share the completed form using the provided options.
Complete your documents online efficiently by following this guide.
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A substantial amendment in the context of the Medicines and Healthcare products Regulatory Agency (MHRA) significantly impacts the study's design or conduct. Changes affecting participant safety, study outcomes, or regulatory compliance fall within this category. Therefore, these substantial amendments must be addressed in your UAHS RIA Amendment Application.
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