Researcher Toolkit
The documents below were created to assist investigators and research coordinators at various timepoints throughout a research study. These templates are intended as guidance documents and may require modifications to fit the specific needs of individual studies. Some of the documents or tools may not be applicable to all studies. Many studies may require the development and use of additional source documentation worksheets to capture all required study data.
If you have questions or need assistance developing source documentation worksheets for your study, please contact:
Melissa Beavers, CCRP
Associate Director, Research Quality Assurance and Improvement
melissabeavers@southalabama.edu
| Document Name / Link | Description |
| Biobanking Protocol Template | Required for projects wishing to bank biospecimens, either temporarily or indefinitely, in labs existing outside of the USA Health Biobank. |
| Data Safety Monitoring Plan Template | A written plan for monitoring research data and the safety of study participants. DSMPs are required for clinical studies involving more than minimal risk. |
| Protocol Template - Biomedical Clinical Trial | Protocol Template for Biomedical Clinical Trials, compliant with ICH E6 (R3) guidelines |
| Document Name / Link | Description |
| Adverse Event Log | Primarily used in clinical research to systematically record, track, and manage all unfavorable medical occurrences experienced by study participants, regardless of whether they are considered related to the investigational product. |
| Corrective and Preventative Action (CAPA) | Documentation of corrective and preventative actions taken when a major finding of non-compliance occurs. |
| Eligibility Checklist | Lists out each inclusion / exclusion criteria for the study and used verify and record whether a prospective participant meets all approved protocol requirements before they are enrolled. |
| IP Transport and Chain of Custody Form | Documents the transport of Investigational Product (IP) from one location to another, documenting the temperatures, location, batch/lot numbers and chain-of-custody sign off |
| Medical History Log | Records a participants current and past medical history, as directed by the study protocol |
| Note to File Template | Standalone memo to place in the study files to document an isolated fact, clarify an error, or explain missing data that is not captured by standard study forms. |
| Off Study Form | Formally documents when and why a participant's enrollment in the research study has ended. |
| Screening / Enrollment Log | Tracking tool used to document every individual evaluated for a research study, capturing their eligibility status, consent details, and enrollment or exclusion details |
Guidance on Informed Consent, along with consent templates and the University of South Alabama Consent Local Context Language can be found on our Consent Webpage.