Documentation Required for Clinical Trials
| Parameter | United States | Canada | Europe |
| Submission name | IND application | CTA | CTA |
| General | Form FDA 1571 | Form HC-SC3011 | EudraCT registration |
| Table of contents; introductory statement | Table of contents | CTA application form for competent authority and ethics committee | |
| Related to clinical trial conduct | General investigation plan | PSEAT-CTA (protocol synopsis) | Protocol synopsis |
| Clinical protocol | Clinical trial protocol | Clinical trial protocol | |
| Informed consent form | Informed consent form | Informed consent form | |
| Case report forms, standard operating procedures, etc. | Case report forms, standard operating procedures, etc. | ||
| Related to radiopharmaceutical | Investigator’s brochure | Investigator’s brochure (including nonclinical and clinical data) | Investigator`s brochure |
| CMC | CMC summary information; (module 2) and supplemental information (module 3) | IMPD including quality, pharmacology, toxicology, and clinical data of investigational medicinal product | |
| Pharmacology and toxicology data | |||
| Previous human experience clinical reports | |||
| Others | Dosimetry; letter of access to cross-referenced IND or master file (if applicable) | Letter of access to cross-referenced master file (if applicable) | Additional information (facility and staff, financial issues [insurance, compensations, agreements]) |
PSEST = protocol safety and efficacy assessment template.