Study Documentation Tools
According to the International Conference on Harmonization Good Clinical Practice (ICH GCP), a key responsibility of an investigator is to maintain trial-related documents that permit evaluation of the conduct of a study and the quality of the data produced. These Essential Documents include participant documents, regulatory binder documents, and protocol assessment-related documents.
The customizable tools provided below are optional, but highly recommended to assist study teams in meeting protocol and regulatory standards.
Participant Files
These tools will help you manage participant documentation for your research study:
- Concomitant Medication Log Template
- Deviation Log Template
- Documentation of Informed Consent Template
- Eligibility and Randomization Checklist Template
- Note to File Template
- Subject Investigational Product Dispensation Log Template
Regulatory Binder Files
These tools will help you manage regulatory documentation for your research study:
- Adverse Event Reporting Log Template
- CAPA Plan Template
- Checklist for Non-Clinical Trial Human Research
- Checklist for Non-IND or -IDE Human Research
- Confidential Subject Identification Code Template
- Delegation of Authority Log Template
- Good Clinical Practice Training Log Template
- Investigational Product SOP Template
- Investigational Product Storage Temperature Log Template
- IRB Submission Log Template
- Manual of Procedure Template
- Participant Pre-Screening and Enrollment Log Template
- Participant Withdrawal and Termination Log Template
- Reportable Events Log Template
- Sample Tracking Log Template
- Site Visit Log Template
- Staff License and Certification Log Template
- SOP Template
- Study Identification Template
- Study Training Log Template
Self-Assessment Review Tools
These tools are easy-to-use checklists that will help you assess your study documentation and conduct in multiple areas, including protocol adherence, inclusion/exclusion adherence, and informed consent documentation:
- Self-Assessment Review Checklist
- Protocol Adherence Assessment Checklist
- Inclusion/Exclusion Adherence Assessment Checklist
- Consent Documentation and Process Adherence Assessment Checklist