1. Protocol Summary
The protocol summary should contain the study objectives, design overview, inclusion/exclusion criteria, and patient safety information. It should also include any changes or deviations from the original protocol that were approved by regulatory authorities.
2. Investigator Information
This includes information about the investigator, such as their qualifications, contact details, and any clinical research experience they may have.
3. Investigational Product Documentation
This should include any documentation related to the investigational product such as manufacturing and distribution information, product labeling, and stability data.
4. Informed Consent Forms & Clinical Trial Agreements
This should include the original copy of the informed consent form, signed by each participant, as well as any amendments or modifications that were made to it. It should also include clinical trial agreements between the sponsor and investigator(s).
5. Adverse Event Reporting Logs and Summaries
Adverse event reporting logs and summaries should be included to document any adverse events that occurred during the trial.
6. Case Report Forms (CRFs)
CRFs are completed for each patient enrolled in the trial and should include information on the study objectives, treatment regimen, outcomes, and any adverse events that occurred.
7. Source Data Verification Records
Source data verification records provide assurance that the information in the CRFs was obtained from source documents.
8. Drug Accountability Records
These records detail drug receipt, storage, and use throughout the trial in order to ensure efficient drug management and compliance with regulations.
9. Lab Results and Quality Control Reports
These should include any lab results obtained from the trial, as well as any quality control reports that ensure data accuracy and integrity.
10. Clinical Study Reports, Regulatory Submissions, and Correspondence with Health Authorities
These documents provide an overview of the trial, its objectives, results, and any conclusions that were drawn from it. It should also include any submissions made to regulatory authorities and any correspondence related to these submissions.
11. Audit Trails
Audit trails document the changes that were made to any documents relating to the trial.
12. Monitoring Visit Reports
These reports provide an overview of the monitoring visits that were conducted throughout the trial and any findings or observations that were made.
13. Training Documents
These documents provide evidence that the study team was adequately trained to carry out the trial.
14. Electronic Data Capture Systems Validation Documents
These documents provide evidence of the validation and accuracy of any electronic data capture systems used during the trial.
15. Statistical Analysis Plans
These plans detail the methods used to analyze the data collected from the trial and any assumptions made during the analysis.
16. Laboratory Certified Study Specimens
Study specimens that have been tested and certified in a laboratory should be included to verify the data collected from the trial. They can also be used for future reference or additional testing if needed.