Significant Open Questions
UTRN assigment
Should the REBRAC require that the registrant obtain a UTRN prior to publishing a trial record?
Answer::
We can apply the same procedure used by Clinical Trial Registry - India, as stated in their data set description: "The UTRN is a number, obtained by the trial's sponsor or principal investigator from http://www.who.int/ictrp/registration/utrn/en/index.html as the first step in registering a trial on the CTRI. The UTRN will then become part of the trial's international identity along with the CTRI registration number. A trial may have a UTRN but may not be fully registered in the CTRI and receive only a provisional CTRI number unless all required dataset items are fully disclosed."
Open to prospective registrants
Primary Registries will: [...] Be open to all prospective registrants.
WHO Primary Registry Criteria, v.2.1, 1. Content, p.2
How can this requirement be reconciled with the requirement that CTs be registered at the CONEP system first?
Answer::
There is no conflict between a prospective registrant and a registrant at CONEP. All registries require an identification from a ethical review board (letter of approval) as a proof of trial existence. It would be better if registries from CONEP system, Plataforma Brasil, could be imported to Primary Registries. Also the registration number at Plataforma Brasil must be informed when registering at REBRAC.
Lifecycle of records
Primary Registries will: [...] Endeavor to keep registered information up-to-date.
WHO Primary Registry Criteria, v.2.1, 1. Content, p.2
What is the lifecycle of a CR record? Proposed workflow states are draft, pending, rejected, published, but this does not take into account the need for updates.
Answer::
Outdated could be another category of the proposed workflow. The system will send a message to the registrant after the completion of the study reminding him/her to update the registry. To be efective, it´s necessary to have a field with the date of study completion.
Standard Operating Procedures
Registries must have processes in place to maximize the possibility that the data registered is complete and accurate. These processes should be documented as Standard Operating Procedures (SOPs).
WHO Primary Registry Criteria, v.2.1, 2. Quality and Validity, p.2
Are the SOPs of current Primary CTRs published? Where?
Search criteria
What are the required and desirable search criteria for CTRP operators and for end-users?
Reports
What are the required and desirable reports for CTRP operators, for registrants and for end-users?
Duplicates
Why the emphasis on reducing duplicate registrations? What would a registrant gain by submitting multiple records for the same trial?
ICTRP IT Officer
WHO Primary Registry Criteria, v.2.1, 5. Technical Capacity, p.3 mentions an ICTRP IT Officer. Who is that person, and how to contact she/he?
ICTRP mailing list
Is there one, to allow information sharing among Primary CTRs and the ICTRP?
Answer::
Tes, you can subscribe to the ICTRP mailing list at http://www.who.int/ictrp/news/enote_subscribe/en/index.html
Scope of searches
When a user issues a query at a register instance, the search activity will span through all information sources present at the register instance, including the register instance itself. An information source can be another register instance or any other information provider or search engine.
Vision Report v.0.7, section 4.2, p.10
What is a precise definition of "information source"?
"Any other information provider or search engine" must be qualified so that this requirement can be implemented.
