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Documentation required to manage the contract

IDIBGI manages contracts for clinical trials, observational studies and research projects at the ICS, IAS and ICO in Girona, among others, both internally (promoted by the researcher him/herself) and externally (promoted by a pharmaceutical company, associations and foundations, other hospitals, etc.).


In order to carry out a clinical trial or study, the contract form must be completed and send it to the responsible person, the clinical study manager at IDIBGI: contractes.eecc@idibgi.org.


The contract models have to be used and filled out taking into account the institution where the activity is carried out and the suitability of the centre has been obtained, as well as the type of clinical study (clinical trial, observational study or research project).

ICS: Institut Català de la Salut - Hospital Universitari Dr. Josep Trueta de Girona

Clinical Trial Contract

Request the contract template at: contractes.eecc@idibgi.org

Along with the contract, the following documentation must be attached at the time of submission:

  1. Document with basic information about the clinical trial and its medication: IDI-FOR-072 - Dades assajos clínics.
  2. Attach the trial protocol.
  3. Favorable opinion from the reference CEIM.
  4. Approval from the Spanish Agency of Medicines and Medical Devices (AEMPS).
  5. Coordination with the Technical Office for Clinical trials to obtain the center’s approval. Contact: recercaclinica@idibgi.org / Tel. 872 987 087 Ext. 301 / 302
  6. Confidentiality agreement in case there is a monitor.
  7. Detailed economic report (ME). Complete the financial data using the Excel model: Model ME - ICS, and also attach the ME in the sponsor’s format.
  8. Copy of the clinical trial insurance policy where the center and the principal investigator are listed.

Observational Studies Contract

Request the contract template at: contractes.eecc@idibgi.org

Along with the contract, the following documentation must be attached at the time of submission:

  1. Attach the study protocol.
  2. Favorable opinion from the reference CEIM.
  3. Approval from the Spanish Agency of Medicines and Medical Devices (AEMPS), only in the case of an observational study with medication.
  4. Coordination with the Technical Office for Clinical trials to obtain the center’s approval. Contact: recercaclinica@idibgi.org / Tel. 872 987 087 Ext. 301 / 302
  5. Confidentiality agreement in case there is a monitor.
  6. Detailed economic report (ME). Complete the financial data using the Excel model: Model ME - ICS, and also attach the ME in the sponsor’s format.

Research Project Contract

Request the contract template at: contractes.eecc@idibgi.org

Along with the contract, the following documentation must be attached at the time of submission:

  1. Attach the project protocol.
  2. Favorable opinion from the reference CEIM.
  3. Coordination with the Technical Office for Clinical trials to obtain the center’s approval. Contact: recercaclinica@idibgi.org / Tel. 972941323 or 972942581
  4. Confidentiality agreement in case there is a monitor.
  5. Detailed economic report (ME). Complete the financial data using the Excel model: Model ME - ICS, and also attach the ME in the sponsor’s format.

 

Amendment to a contract

Along with the amendment document, the following must be attached:

  1. New version of the protocol with tracked changes highlighted.
  2. Favorable opinion from the reference CEIM for the new protocol.
  3. Coordination with the Technical Office for Clinical trials to obtain the center’s approval. Contact: recercaclinica@idibgi.org / Tel. 972941323 or 972942581
  4. New AEMPS approval, if applicable.
  5. New economic report, if applicable.
IAS: Institut d'Assistència Sanitària - Hospital Santa Caterina de Salt (Girona)

Clinical Trial Contract

Request the contract template at: contractes.eecc@idibgi.org

Along with the contract, the following documentation must be attached at the time of submission:

  1. Document with basic information about the clinical trial and its medication: IDI-FOR-072 - Dades assaigs clínics.
  2. Attach the trial protocol.
  3. Favorable opinion from the reference CEIM.
  4. Approval from the Spanish Agency of Medicines and Medical Devices (AEMPS).
  5. Coordination with the Technical Office for Clinical trials to obtain the center’s approval. Contact: recercaclinica@idibgi.org / Tel. 972941323 or 972942581
  6. Confidentiality agreement in case there is a monitor.
  7. Detailed economic report (ME). Complete the financial data using the Excel model: Model ME - IAS, and also attach the ME in the sponsor’s format.
  8. Copy of the clinical trial insurance policy where the center and the principal investigator are listed.

Observational Studies Contract

Request the contract template at: contractes.eecc@idibgi.org

Along with the contract, the following documentation must be attached at the time of submission:

  1. Attach the study protocol.
  2. Favorable opinion from the reference CEIM.
  3. Approval from the Spanish Agency of Medicines and Medical Devices (AEMPS), only in the case of an observational study with medication.
  4. Coordination with the Technical Office for Clinical trials to obtain the center’s approval. Contact: recercaclinica@idibgi.org / Tel. 972941323 or 972942581
  5. Confidentiality agreement in case there is a monitor.
  6. Detailed economic report (ME). Complete the financial data using the Excel model: Model ME - IAS, and also attach the ME in the sponsor’s format.

Research Project Contract

Request the contract template at: contractes.eecc@idibgi.org

Along with the contract, the following documentation must be attached at the time of submission:

  1. Attach the project protocol.
  2. Favorable opinion from the reference CEIM.
  3. Coordination with the Technical Office for Clinical trials to obtain the center’s approval. Contact: recercaclinica@idibgi.org / Tel. 972941323 or 972942581
  4. Confidentiality agreement in case there is a monitor.
  5. Detailed economic report (ME). Complete the financial data using the Excel model: Model ME - IAS, and also attach the ME in the sponsor’s format.

Amendment to a contract

Along with the amendment document, the following must be attached:

  1. New version of the protocol with tracked changes highlighted.
  2. Favorable opinion from the reference CEIM for the new protocol.
  3. Coordination with the Technical Office for Clinical trials to obtain the center’s approval. Contact: recercaclinica@idibgi.org / Tel. 972941323 or 972942581
  4. New AEMPS approval, if applicable.
  5. New economic report, if applicable.
ICO: Institut Català d'Oncologia - Centre de Girona (Edifici Hospital Universitari Dr. Josep Trueta de Girona)

Clinical trials contract

Request the contract template at contactfortrialsicogir@iconcologia.net

Observational trials contract

Request the contract template at contactfortrialsicogir@iconcologia.net

Research project Contract

Request the contract template at contactfortrialsicogir@iconcologia.net

Amendment to a contract

Along with the amendment document, the following must be attached:

  1. A new version of the protocol with change tracking highlighted.
  2. A favorable opinion from the reference CEIM for the new protocol.
  3. New approval from AEMPS, if applicable.
  4. A new economic report, if applicable.

Study notifications and follow-up

The sponsor of the clinical trial must notify by e-mail: admin.eecc@idibgi.org , the following data in order to keep track of the status of the clinical trial:

  • Notification of commencement
  • End of recruitment
  • End of clinical study at the centre

In addition, any changes to the contact details of the promoter or CRO should also be notified by e-mail.

Fees and invoicing

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:

ICS (Hospital Univ. Dr. Josep Trueta) or IAS (Hospital Santa Caterina) centers costs
IDI-DOC-036 ENG
ICO (Institut Català d'Oncologia de Girona) center costs

 

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.

Contact

Martí Benítez
Clinical Trials technician - Legal and economical management of contracts


Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
C/ Dr. Castany s/n, 17190, Salt
Parc Hospitalari Martí i Julià - Edifici M2
E-mail: contractes.eecc@idibgi.org
Tel: 872.987.084 ext. 331
Ekram el Fachtali Rifi
Clinical Trials Administrative - Invoicing


Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
C/ Dr. Castany s/n, 17190, Salt
Parc Hospitalari Martí i Julià - Edifici M2
E-mail: admin.eecc@idibgi.org
Tel: 872.98.70.87 (Ext. 13)

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