This toolkit offers templates to assist research teams with conducting, tracking and/or monitoring research activities. These documents are available for research teams to download and adapt for their own use.
|Adverse Event Log||September 2021|
|Central IRB Protocol & Consent Version Logs||October 2023|
|Communication Log||June 2020|
|Close-Out Checklist||December 2022|
|Deviation Log||June 2020|
|Device Accountability Log||June 2020|
|Documentation of Informed Consent - Consent, Assent, Parental Permission||June 2020|
|Documentation of Informed Consent||June 2020|
|Drug Accountability Log||June 2020|
|Material Transfer Agreements (MTA) and/or Data Transfer Agreements (DTA) Checklist||September 2021|
|Medical History||June 2020|
|Monitoring Visit Log||June 2020|
|Note to File||June 2020|
|Participant Screening/Enrollment Log||June 2020|
|Participant Withdrawal Form Template||November 2022|
|Sample Tracking Log||June 2020|
|Serious Adverse Event Log||June 2020|
|Site Initiation Visit (SIV) Checklist||April 2022|
|Study Delegation Log||August 2022|
|Study Drug Compliance Log||June 2020|
|Telephone Contact Form||June 2020|
|Training Log||November 2021|
Yes. Investigators and researchers are free to add/remove fields on these templates in order to meet the needs of their specific studies. Researchers should use these templates as guidance for the type of data that should be collected and documented, and feel empowered to adapt the contents where needed. For example:
- for studies with an external sponsor, a column might be added to the “Deviation Log” to document if the deviation was reported to the study sponsor.
- for protocols that do not include a study drug, tasks relating to drug accountability and dispensing (i.e., #14-15) could be removed from the “Study Delegation Log”.
- For all study types, a column could be added to the “Training Log” indicating the Type of Trainingperformed (e.g., in-person, virtual presentation, e-mail summary with self-review, self-review, other).
These are only a few examples of the types of modifications that could be made and does not represent an complete summary.
If the sponsor has provided a form and asked study sites to use their form, then the sponsor form should be used. If you feel the UU form has an advantage over the sponsor-provided form, you may make a request to the sponsor to use the UU form by submitting the UU form with an explanation of the proposed advantage(s) to the sponsor. Some sponsors may provide template forms which are optional for use and the sponsor may not have a preference for which form is used, as long the required content is captured.