Field 3. Secondary Identifying Numbers
WHO description
Other identifying numbers and issuing authorities besides the Primary Registry, if any. Include the sponsor name and sponsor-issued trial number (e.g., protocol number) if available. Also include other trial registries that have issued an identifying number to this trial. There is no limit on the number of Secondary identifying numbers that can be provided.
Schema
Multiple records each with issuing organization and identifying number.
Validation
Validate format of UTN (apply validation formula, if it is published).
Labels
EN: Secondary Identifying Numbers
PT: Identificadores secundários do ensaio
ES: Identificadores secundários
Sample Values
- sample 1 (UTN)
- issuing organization: WHO/ICTRP
identification number: U1111-1111-4101
- sample 2 (Plataforma Brasil)
- issuing organization: Comissão Nacional de Ética em Pesquisa (CONEP)
identification number: 1234567890???
sample 3
issuing number: ANVISA (comunicado especial)
identification number:
sample 4
number assigned by the institutional review board/ ethics committee upon approval of the protocol for studies in foreign countries(no sites of recruitment in Brazil).
sample 5
number assigned by a primary / partner clinical trial register
Questions
- Should we offer a controlled vocabulary or at least suggestions for the issuing organization field?
- How can an UTN be validated?
Answer: if we adopt the UTN associated with a code (RBC) to compose the identification number, this validation wouldn´t be necessary.
- If it is an international multicentric study that was registered in a previous primary registry, should we recommend to use the same UTN number in order to avoid duplication of records at ICTRP?
Answer: No. We should request the registrant to fill up the number and issuing organization in one the secondary identifying number fields.
Executive Committee decisions (2009-08-06)
- UTN will be required
Executive Committee decisions (2010-02-23)
- Suggested vocabulary for issuing authority in RBEC
| mandatory | authority | description | example |
| Y | ICTRP/WHO | UTN | ???? |
| Y | Patrocinador | Código gerado pelo patrocinador | (free format) |
| - | CONEP | CAAE | 1234.1.123.123-12 |
| - | CEP | nº do parecer | (free format) |
| - | ANVISA | CE - Comunicado Especial | 12345678/1234 |
| - | CNPq | Número do contrato | ??? |
| - | ClinicalTrials.gov | Identifier | NCT12345678 |
Part of: TrialRegistrationDataSet
