Send the adapted and completed model contract with the details of the trial and the promoter to aacc@idibgi.org
The following documents must be enclosed with the contract at the time of mailing:
1. Document with basic information on the clinical trial and its medication:
2. Also attach the Study Protocol and favourable opinion from the reference CEIC.
3. Annex I to the contract - Confidentiality document signed by the monitor.
The centre requires a contract to be completed and signed with the company monitoring the clinical trial to regularise the commissioning of the processing of personal data in the framework of the clinical trial.
For any comments or questions regarding the RGPD contract for the monitor, please contact: rgpd.girona.ics@gencat.cat
4. Annex II - Detail of the economic report of the clinical trial. Complete the economic data with the model in Excel format. Also attach the ME with the promoter's pdf format for verification.
5. Annex III - attach the copy of the study/centre insurance policy.
IMPORTANT: Remember that the study must be presented at our Technical Office for Clinical trials. The Hospital's management will not sign any contract that DOES NOT have their certificate/approval. However, we can negotiate and initiate the signature process in parallel with the Technical Office presentation.
Send the adapted and completed contract model with the data of the asssessment and the promoter to aacc@idibgi.org
The following documents must be enclosed with the contract at the time of mailing:
1. Attach the test protocol and the favourable opinion of the CEIM of reference.
2. Annex I - Confidentiality document signed by the monitor or company to which the monitor belongs.
The centre requires a contract to be completed and signed with the company monitoring the clinical trial to regularise the commissioning of the processing of personal data in the framework of the clinical trial.
For any comments or questions regarding the RGPD contract for the monitor, please contact: rgpd.girona.ics@gencat.cat
3. Annex II - Detail of the economic report of the clinical trial. Complete the economic data with the model in Excel format. Also attach the ME with the promoter's pdf format for verification.
IMPORTANT: Remember that the study must be presented at our Technical Office for Clinical trials. The Hospital's management will not sign any contract that DOES NOT have their certificate/approval. However, we can negotiate and initiate the signature process in parallel with the Technical Office presentation.
Send the adapted and completed amendment form with the trial/study and promoter data to aaacc@idibgi.org
It must be attached to the amendment document:
1. Attach the protocol amendment document or the protocol with the tracking of changes highlighted (the protocol that gives rise to the new amendment to the initial contract).
IMPORTANT: Remember that the study must be presented at our Technical Office for Clinical trials. The Hospital's management will not sign any contract that DOES NOT have their certificate/approval. However, we can negotiate and initiate the signature process in parallel with the Technical Office presentation.
Send the adapted and completed model contract with the details of the trial and the promoter to aacc@idibgi.org
The following documents must be enclosed with the contract at the time of mailing:
1. Document with basic information on the clinical trial and its medication:
2. Also attach the Study Protocol and favourable opinion from the reference CEIC.
3. Annex I to the contract - Confidentiality document signed by the monitor.
The centre requires a contract to be completed and signed with the company monitoring the clinical trial to regularise the commissioning of the processing of personal data in the framework of the clinical trial.
For any comments or questions regarding the RGPD contract for the monitor, please contact: rgpd@ias.cat
4. Annex II - Detail of the economic report of the clinical trial. Complete the economic data with the model in Excel format. Also attach the ME with the promoter's pdf format for verification.
5. Annex III - attach the copy of the study/centre insurance policy.
IMPORTANT: Remember that the study must be presented at our Technical Office for Clinical trials. The Hospital's management will not sign any contract that DOES NOT have their certificate/approval. However, we can negotiate and initiate the signature process in parallel with the Technical Office presentation.
Send the adapted and completed contract model with the data of the asssessment and the promoter to aacc@idibgi.org
The following documents must be enclosed with the contract at the time of mailing:
1. Attach the test protocol and the favourable opinion of the CEIM of reference.
2. Annex I - Confidentiality document signed by the monitor or company to which the monitor belongs.
The centre requires a contract to be completed and signed with the company monitoring the clinical trial to regularise the commissioning of the processing of personal data in the framework of the clinical trial.
For any comments or questions regarding the RGPD contract for the monitor, please contact: rgpd@ias.cat
3. Annex II - Detail of the economic report of the clinical trial. Complete the economic data with the model in Excel format. Also attach the ME with the promoter's pdf format for verification.
IMPORTANT: Remember that the study must be presented at our Technical Office for Clinical trials. The Hospital's management will not sign any contract that DOES NOT have their certificate/approval. However, we can negotiate and initiate the signature process in parallel with the Technical Office presentation.
Send the adapted and completed amendment form with the trial/study and promoter data to aacc@idibgi.org
It must be attached to the amendment document:
1. Attach the protocol amendment document or the protocol with the tracking of changes highlighted (the protocol that gives rise to the new amendment to the initial contract).
IMPORTANT: Remember that the study must be presented at our Technical Office for Clinical trials. The Hospital's management will not sign any contract that DOES NOT have their certificate/approval. However, we can negotiate and initiate the signature process in parallel with the Technical Office presentation.
Send the adapted and completed model contract with the details of the trial and the promoter to aacc@idibgi.org
NOTE: To carry out an observational study contract, the clinical trial model must be adapted. We do not have a model for a trial and another for a clinical study.
The following documents must be enclosed with the contract at the time of mailing:
1. Document with basic information on the clinical trial and its medication:
2. Also attach the Study Protocol, favourable opinion from the reference CEIC and patient informed consent.
3. Annex I - Detail of the economic report of the clinical trial. Complete the economic data with the model in Excel format. Also attach the ME with the promoter's PDF format for verification.
4. Radiological test management contract - If radiological tests are required, a parallel contract must be managed between IDIBGI and PROMOTOR, independent of the general contract with the centre.
L'Institut de Diagnòstic d'Imatge (IDI) is an independent body and technical service belonging to the Administració de la Generalitat de Catalunya, the Servei Català de la Salut and the linked and dependent entities, by virtue of article 18.3 of the IDI’s statutes, modified by the GOV/38/2015 government agreement in the session held on March 17th, 2015 (DOGC no. 6834, dated 2015.03.19), and to this effect it can assume commissions of management from these entities.
The IDIBGI instructs the IDI to carry out radiological tests when the trial is in-house. The SPONSOR will not have direct contact with the IDI, the concepts and management will be carried out through IDIBGI
Send the adapted and completed model contract with the details of the trial and the promoter to aacc@idibgi.org
NOTE: To carry out an observational study contract, the clinical trial model must be adapted. We do not have a model for a trial and another for a clinical study.
The following documents must be enclosed with the contract at the time of mailing:
1. Attach the Study Protocol, favourable opinion from the reference CEIC and patient informed consent.
2. Annex I - Detail of the economic report of the clinical trial. Complete the economic data with the model in Excel format. Also attach the ME with the promoter's PDF format for verification.
Send the adapted and completed amendment form with the trial/study and promoter data to aacc@idibgi.org
It must be attached to the amendment document:
1. Attach the protocol amendment document or the protocol with the tracking of changes highlighted (the protocol that gives rise to the new amendment to the initial contract).
The sponsor of the clinical trial must notify by e-mail: aacc@idibgi.org , the following data in order to keep track of the status of the clinical trial:
In addition, any changes to the contact details of the promoter or CRO should also be notified by e-mail.
The management and processing of contracts and amendments for clinical studies have a single, non-refundable cost that will be stated in the contract.
IDIBGI offers the possibility of managing the patient transfer service, as well as the custody and archiving of the documentation once the study has been completed.
Fees can be consulted below:
Invoicing: Unless otherwise agreed in the contract, the Developer undertakes to request invoices on a quarterly basis as from the signing of the contract, which will include the clinical visits carried out and monitored up to that time together with any additional budget items that may apply.
Once the information in the request has been corroborated, IDIBGI will issue the corresponding invoice.
This invoice has to be paid by the promoter within 30 days from the date of issue.
