We can all agree that protocol amendments create a great deal of work for coordinators and a single amendment can take a long time to implement. We are happy to introduce you to a checklist tool that can be utilized to keep track of all necessary actions when a sponsor sends documents for a protocol amendment.
It is located under Coordinator Corner > Tools/Templates > Protocol Amendment Checklist
Few notes on how this checklist can be helpful:
1. Most protocol amendments will take somewhere between 1-4 months to implement, from the moment we submit to ccto-intake for processing to IRB approval and/or contract execution. This checklist is designed to help you plan ahead and serve as a reminder of what needs to be done (e.g., when you get the IRB approval after 2 months of initial submission or when you get the amended contract executed after 4 months, by referring to this checklist, you can quickly identify pending action items).
2. It will help with self-monitoring of study requirements (e.g., who still needs to be trained?).
3. This checklist can be used as a guide when discussing protocol amendments with your PI or your manager, depending on how your CRG functions. It is totally optional to use the “Review and Signoff” section but remember to remove the section if you do not plan on implementing this process (otherwise the checklist will appear incomplete!).
4. When you take over studies from other coordinators or need to refer back to previous protocol amendments, if this checklist was completed, you may be able to find your answers quickly! (e.g., Why was subject 001 not re-consented?)
5. This checklist was created to serve as a template but is not a requirement. Feel free to modify to meet your study-specific or group-specific needs!
If you have any questions or suggestions, please reach out to firstname.lastname@example.org and email@example.com.