This document describes the definitions for protocol registration data elements submitted to for interventional studies (clinical trials) and observational studies. These definitions are mostly adapted from
42 CFR Part 11 .
Data element entries are annotated with symbols to indicate generally what information is required to be submitted (and under which circumstances). The responsible party must ensure that the information provided complies with any applicable laws, regulations, or policies. For more information about various requirements and definitions of regulatory terms under 42 CFR Part 11, see Support Materials .
Note : The term "clinical study" is used to refer to both interventional and observational studies. The term "participant" is used to refer to human subjects.
* Required * § Required if Study Start Date is on or after January 18, 2017 [*] Conditionally required
1. Study Identification
We are not experts on many of the subjects that we map but are aware that international data can be unsatisfactory and inadequate. By making such data more accessible, we hope to encourage the provision of good quality international data. If you have advice on how to improve it, please approach the organisation, given in the technical notes, providing our data. We would like to be told of secondary sources of data for territories where we have had to make estimates. We would also appreciate any essential comment about the data that you feel needs to be added to the technical notes. (email [email protected] )