The Studies and Agreements Register Unit (UAdEC), associated to the Technical Secretariat of the Germans Trias i Pujol University Hospital (HUGTiP) Research Ethics Committee, is in charge of the administrative management of agreements for clinical trials and research projects.
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In order to start managing the agreement it is mandatory for the study to be registered at the site:

- Clinical trials with medicinal productsor medical devices will be registered by requesting the suitability of the facilities document to the secretariat of the HUGTiP Research Ethics Committee.
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- Other kind of studies will be registered by submitting the initial assessment application to the HUGTiP REC.

Once the study is registered, it will be possible to manage the agreement by sending the following documents to this email address uadec.germanstrias@gencat.cat:

REQUIREMENTS
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 REQUIREMENTS FOR THE ADMINISTRATIVE MANAGEMENT OF THE AGREEMENT
 REQUIREMENTS FOR THE ADMINISTRATIVE MANAGEMENT OF AND ADDENDUM TO THE AGREEMENT

PROCEDURE

1. The sponsor will send the required documents to the following email address -uadec.germanstrias@gencat.cat
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2. The site will examine the draft and will let the sponsor know about the changes or clarifications that the documents may need.
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3. Once both parties have agreed on a final version of the draft, the sponsor will begin the signature process. The sponsor will send to the UAdEC 4 original copies printed on a single side with the sponsor’s legal representative signature on every page.
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4. Once the copies are received, the site will start the signature process: Principal Investigator > IGTP > HUGTiP.
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5. When the agreement is signed by all the parties, the UAdEC will make sure all the requirements are met and will notify the sponsor so that they can collect their copy.

FEE

The administrative management of the agreement carries a €1,500 (+ VAT) fee that the sponsor will pay once all the parties sign the agreement. The invoice will be previously issued by the Institute for Health Science Research Germans Trias i Pujol (IGTP).
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This fee is applicable to all billable agreements. The fee payment will not depend on the effective conduct of the study or the receipt of approval from the Research Ethics Committee and/or the AEMPS.
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In case of non-billable agreements with independent non-commercial sponsors, it will be possible to request a fee waiver by sending a letter to the UAdEC signed by the sponsor.
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