Requirements for the presentation of observational drug studies and their amendments If you would like our Clinical Research Ethics Committee (CEIm) to be the CEIm within Spanish territory for your observational drug study (ODS), you must send an application email to firstname.lastname@example.org, indicating the study information and the approximate date of presentation thereof.t regions here. Definition of ODS Documents presentation Timeframe for presentation: Can be presented at any time. All documentation must be presented exclusively by email to email@example.com. All documentation may be written in English, except for the following documentation, which must be presented in Spanish: Study summary. Patient information sheet and informed consent. Documentation addressed to the patient. Requirements for the submission of initial ODS evaluation requests See the requirements for the ODS evaluation request here. Information the protocol must contain: Refer to Annex I of the RD 957/2020. More information on the Memorando de colaboración entre los Comités de Ética de la investigación con medicamentos para la evaluación y gestión de los Estudios Observacionales con Medicamentos. We have a guide for the correct elaboration of a Patient Information/Informed Consent Form for observational studies with medicinal products (EOM) as well as different models of Patient Information/Informed Consent Forms. Informed Consent Form Model. Informed Consent Form Model in case of presence of witnesses. Informed Consent Form Model in case of minors. In the case of a unicentric study, you can use and adapt the Informed Consent Form Model for independent promotion ODS. Note for internal researchers: If you do not have a model, you can use and adapt the models we have for research projects: Research project report/Protocol. You must include the version and the date of the document at the foot of it. Local documentation models Document of the principal investigator/collaborators and acceptance from the departments involved. It must include the Principal Investigator's department head. Fee exemption request to the CEIm. You must add the Promoter at the document. This request must be justified in the Reasons section of the document. Temporary waiver of CEIm evaluation fees: only in the case of grants pending resolution. NOTE. Once the grant is approved, the CEIm must be informed if funding is available to pay the fees and apply for the invoice (by sending an email with the billing information for the invoice to firstname.lastname@example.org). Otherwise, if you have not received funding, request the exemption of fees by email (email@example.com). Relevant amendments Local requirements and documentation: Request for evaluation of ODS amendments In the case of amendments, the modified documents must always be presented with the changes marked. Relevant amendments to local aspects of the centre Each centre will internally evaluate local changes, such as, for example, changing the principal investigator. The centre will provide acceptance of the amendment and no evaluation or approval by the CEIm is required. In the case of our centre: See the section "ODSs approved by another CEIm in Spain - local evaluation of the centre", located below. Prospective monitoring ODS Formalities with the Spanish Drug and Medical Device Agency (AEMPS) - Spanish Registry of Clinical Studies (REec) / GESTO: It is obligatory to publish the ODS on the REec through the GESTO site. Informative note from the AEMPS GESTO site: Initially, they must include, at least: Title, sponsor, drugs under study, main objective and sources of funding. It is mandatory to keep the information updated (amendments, final report, publishing, etc.). For ODSs that do not involve prospective monitoring, registration in the REec / GESTO and follow-up updates are optional. Procedures with the Autonomous Community of Catalonia: For studies in which the sponsor is a public entity or those which are accredited as being clinical research without a commercial goal, no further authorisation is necessary from the autonomous communities. However, you should present the study documentation through the telematic process provided by the Generalitat of Catalonia on their website to register the event: ODS approved by another CEIm in Spain - local evaluation of the centre Initial presentation Only one CEIm resolution is necessary for the whole Spanish territory. The centre will issue an acceptance for the completion of the study at the centre, but no evaluation or approval by CEIm is required. You must perform the steps with the centre via email at firstname.lastname@example.org. Necessary documentation: Study protocol. Favourable resolution from the CEIm. Commitment of the principal investigator and collaborators/Acceptance from the departments involved. You must include the Principal Investigator's department head. Curriculum vitae of the principal investigator. Amendments and notifications: Amendments and notifications should not be sent to the dREC, since they do not need to be evaluated or approved by it. They should only be sent to the centre (via email at email@example.com), who will issue the local amendment acceptance for the study in the centre. The CEIm approval resolution must be included. Presentation for a change of principal investigator at Vall d'Hebron University Hospital You need to submit the following documents by email to firstname.lastname@example.org: Local document regarding the principal investigator/collaborators and acceptance of the departments involved. Curriculum vitae of the principal investigator. Contract and billing To request the contract model or for any questions related to the contract, contact the Legal Department of the Foundation: email@example.com. Economic Report: To request the local model or for any questions related to the economic report, contact the following email: firstname.lastname@example.org. For any questions regarding billing, contact the Department of Economic Management of the Foundation via email at email@example.com. Contact If you have any queries, contact the CEIm Support Unit: 13th floor of the Children's Hospital and Women's Hospital Passeig de la Vall d'Hebron, 119-129. 08035 Barcelona Phone: (+34) 93 489 40 10 Email address: firstname.lastname@example.org Contact with different Autonomous Communities You will find the contact details here.