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Registering Clinical Trials

 

In order to register a clinical trial in RPCEC site you should:

- Register as a sponsor or Responsible Registrant (only the first time that you apply for Register a trial in the RPCEC).
- Complete the Spanish and English forms.

  
 


Register as a sponsor (responsible registrant): If it is the first time you are going to register a clinical trial in the RPCEC you need to:

1. Complete the sponsor form to register and send it. (Click here to fill and send the sponsor form)

2. You should send electronic copies of:

- Document to prove the creation of the hospital or institution you would like to register.
- Signed letter by the director of the institution or by the supervisor of the person that the sponsor is designating as responsible registrant.

 
 


After the sponsor form and the documents have been received, the RPCEC staff will process the request (Required time: five working days after the reception of the form and the documents).

If the data are complete, you will receive a notification of registration in our database and that you may register a clinical trial.

If there are missing data in the sent form, you will also receive a notification requesting to complete the information

 
 


It is important you know that:

1. The registration as sponsor is only necessary the first time you register a clinical trial in the RPCEC.
2. The registration as sponsor guarantees a space of work in the register.

 

To complete the registration form of the clinical trial: Once registered as sponsor of clinical trials (you only need to register the first time you register a clinical trial) you need to: 
 


- To complete the Spanish and English forms. You will do:

1. Enter the site with your username and password.
2. To complete the Spanish form, enter to "My Folder". Click "Add New Item". Click "Ensayo Clínico RPCEC" (My Folder->Add New Item->Ensayo Clínico RPCEC).
3. To complete the English form, enter to "My Folder". Click "Add New Item". Click "Clinical Trial WHO" (My Folder->Add New Item-> Clinical Trial WHO).

In each form you can save the data using button “Guardar/Save”

- To send the forms to revision. You will do:

1. Click in the State menu and click "Enviar a Revisión" to send the Spanish form.
2. Click in the State menu and click "Submit to Review" to send the English form.

 
 


Once your forms are completed the registration forms of the clinical trial will be processed (Required time: 15 working days after the reception of the forms)

  
 


- If the data are complete the trial is registered. That means to the both forms receive the same date and the same registration number (the clinical trial is public in the site). You will receive a notification that your clinical trial has been successfully registered in the database with the registration number and confirm the type of registration: prospective or retrospective.

- If there are missing data in the sent form you will also receive a notification requesting to complete the information

 
 
It is important you know that:

1. The translation of the form is responsibility of the sponsor. Clinical trials form in Spanish will not be registered (published) until the English form is not ready to be registered (published). Both forms have the same date and the same registration number. Only the trials registered until July 24, 2008 have different date of registration. They have the same registration number. In those trials the responsibility of the translation in some case was the sponsor and in other case the responsibility of the translation was the registry. PAHO in Havana collaborated with the registry with the translation of the trial records. The services of ESTI were contracted too.

2. The clinical trial must be registered before the onset of patient enrollment. This is a prospective registration. In other case the registration is retrospective.

3. The Registry ever deletes a trial record from the database, or removes it from public view, once a registration number has been issued and the trial is registered.

4. The Registry makes sure that the trial exists with the Cuban regulatory agency (using the reference number for checking). If the high level of approval is the Ethics Committee, then the registry will check with it. Every three months, one member of the registry staff checks the authorization status of all the trials registered during this period.

5. Every trial must be update at least annually (if the “Publications” field in the Spanish form is blank or “Not applicable”). If the trial is not update, the status of the trial will be “Desactualizado/Outdated” instead of “Publicado/Published”. If the trial is recruiting patients, the updating must be frequently.

  
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