CEIm Frequently asked questions 1. When are the committee meetings where the clinical trials are evaluated? The meetings are held every Friday, except holidays and long weekends [puentes]. 2. When do the committee meetings that evaluate research projects take place? The meetings take place on the last Friday of the month. 3. Does your Clinical Research Ethics Committee(CEIm) perform evaluations in August? Yes, except for the evaluation of research projects, which include studies without drugs, using CE-marked medical devices used under authorised and normal conditions of use, sample collections, sample transfers, and studies with food products or food supplements. 4. How long before the meeting must I send in the documentation for a clinical trial with drugs/medical devices or amendments thereof for them to be included in the Friday meeting? The Technical Secretariat cannot provide or calculate an accurate estimated time; the stipulated calendar will be followed and we cannot tell you in advance which meeting will evaluate your proposal. The distribution of evaluations is organised internally by the CEIm based on all requests received at any given time. Please refer to the timeframe stated in RD 1090/2015. 5. I have made an initial presentation/substantial modification presentation for a clinical trial in phase I or phase I/II. When will I receive the resolution for part II? The calendars will be followed as outlined in RD 1090 / 2015. For phase II–IV studies, the set deadline may not be surpassed, but in the case of a phase I [trial] this might happen, as we must wait first to receive the part I evaluation report conducted by AEMPS. Once received, it will be included in the next meeting. For this reason, it is not possible for us to inform the sponsor of exactly when the trial will be evaluated. 6. How much time is available to respond to requests for clarification? You must count 12 days from the day the resolution is received. 7. How should the answers be submitted for clarifications regarding a substantial modification? They must be answered by email: email@example.com. 8. How should the answer be submitted for second clarifications regarding an initial evaluation? Second clarifications must be answered by email: firstname.lastname@example.org. 9. How much time will elapse between the initial evaluation and the resolution being sent? Resolutions are issued during the following week, between Tuesday and Thursday. 10. I have a substantial modification of a clinical drug trial that only applies to part I. Will I receive a resolution? No, since the CEIm only issues resolutions regarding part II. The CEIm will send the part I evaluation report to the AEMPS, but not to the sponsor. For this reason, you will not receive any notifications from the CEIm, in this case. 11. Can I perform an initial presentation of a clinical drug trial if I'm missing a document, in order to move the evaluation forward? No, you need to file the full and valid request. If not, an amendment will be requested, which can be answered within 10 business days. If it's not received in this period, the request may be dismissed. 12. Can I perform a relevant amendment presentation of a clinical drug trial if I am missing a document, in order to move the evaluation forward? No, you need to file a complete and valid request. If not, an amendment will be requested, which can be answered within 6 business days. If it's not received in this period, the request may be dismissed. 13. How is approval from the Generalitat for a post-authorisation Study (PAS) requested? You have to go to the Generalitat of Catalonia's website via this link. 14. How can I request the evaluation invoice for a clinical trial and/or Post-Authorisation Study (PAS)/Observational Drug Study (ODS)? You must contact the Department of Economic Management, via email at email@example.com. 15. Must the Foundation be mentioned in the insurance certificate for the clinical trial? For the evaluation of a clinical trial it is not an indispensable condition that the Hospital Foundation appear on the insurance certificate. The important thing is that the centre is, at least. The addresses are as follows: Hospital Universitari Vall Hebron. Passeig de la Vall d’Hebron 119-129. 08035 Barcelona Fundació Hospital Universitari Vall Hebron – Institut de Recerca [Research Institute].Passeig de la Vall d’Hebron 119-129. 08035 Barcelona Fundació Hospital Universitari Vall Hebron - Institut d’Oncologia VHIO [Oncology Institute]. C/ Natzaret 115-117. 08035 Barcelona 16. What are the presentation requirements for a clinical trial using drugs? The requirements are those listed on the AEMPS website. On our website, you will find a guide for the presentation, based on these requirements. 17. What are the presentation requirements for a post-authorisation study (PAS)? New legislation regarding observational studies came into force in January 2021. If your study has been classified as a post-authorisation study before the entry into force of this new legislation, you will have to contact us via email at firstname.lastname@example.org and we will send you the documentation applicable to the previous legislation. 18. What are the presentation requirements for an observational drug study (ODS)? New legislation regarding observational studies came into force in January 2021. You will find the requirements on our website, specifically, in the section Requirements for evaluating Observational Drug Studies (ODS). 19. What are the requirements for the presentation of clinical research using medical devices? If it is clinical research with a medical device without CE marking, or with CE marking but under unauthorised or uncommon conditions of use, you must submit it according to the requirements listed on our website (see the section Clinical research with medical devices evaluation requirements, RD 1910/2015). If it is clinical research with a CE-marked medical device under both authorised and common conditions of use, you must present it according to the requirements available on our website (see section Research project evaluation requirements). 20. If the initial assessment/substantial modification of a clinical drug trial is presented by the Voluntary Harmonisation Procedure (VHP), how should the national presentation be conducted? The initial resolution request or substantial modification of a clinical trial at CEIm must be made simultaneously with the application for the Voluntary Harmonisation Procedure (VHP). If this is not possible, it is advisable to do so once the VHP procedure is complete. In order to expedite the issuance of the resolution, it is necessary to always indicate in the letter of national presentation that it is a request evaluated by the VHP. The request will include, as appropriate, the documentation to be evaluated or that which has already been evaluated and accepted by the VHP, as well as documentation corresponding to part II, if applicable. If presented at the same time as the VHP and, part II, at the national level, the simultaneous evaluation of both parts will be carried out, thus streamlining national approval. If part II is presented later or after VHP approval, the evaluation schedule will be applicable for part II as detailed in RD 1090/2015. It will not be 15 days, since this term only applies if it is done simultaneously and corresponds to the presentation time of a document at AEMPS. 21. I need to draw up the contract with your centre, as well as obtain the contract model. Do you take care of this? No. To request the contract model or for any questions related to the contract, contact the Legal Department of the Foundation: email@example.com. 22. I have questions about the Vall d'Hebron University Hospital’s economic report model. For the local model request or any questions regarding the economic report, you must contact the following email: firstname.lastname@example.org. 23. I have a clinical trial with drug/medical device or observational drug study being evaluated by another CEIm in Spain. Do I need to arrange anything with your CEIm? No. You must perform the steps with the centre via email at email@example.com. 24. I have an amendment to a clinical trial with drugs/medical devices/observational drug study that has been approved by another CEIm in Spain. Must I notify your CEIm? No. You must notify the centre via email at firstname.lastname@example.org. 25. I need to apply for the suitability of your centre for a clinical trial. Do I need to arrange anything with your CEIm? No. You must perform the steps with the centre via email at email@example.com. 26. I have a study without drugs/ones using CE-marked medical devices and under authorised and common conditions of use approved by another REC/CEIm in Spain. Must it be evaluated by your CEIm? Yes. The requirements can be found on our website, in the section Research project evaluation requirements. 27. What are the contact details for your centre's data protection officer? Data protection officer: firstname.lastname@example.org. The Legal Unit at the Fundació Institut de Recerca - Hospital Universitari Vall d'Hebron can resolve all your questions, complaints, clarifications, suggestions and will address the exercise of rights through the email email@example.com, or by post: Passeig Vall d’Hebron 119-129, Edifici Mediterrània, 2a planta, 08035 Barcelona. For the Vall d’Hebron Institut d’Oncologia (VHIO): firstname.lastname@example.org. 28. Should I send notifications for clinical trial with drugs or medical devices/observational drug studies that have been previously approved by another CEIm to your CEIm? No. They must be sent to the centre via email at email@example.com. 29. Does the CEIm stop the clock during the Christmas holidays? Yes, from 23 December to 7 January the clock stops for all applicable terms. 30. What should I present to the CEIm if I have a satellite centre for the drug clinical trial, and what should I take into account? Certain tests or activities inherent to conducting the trial are performed at a satellite or external centre, one other than the participating centre, for some clinical trials (CT). An external or satellite centres is understood as a location that performs some type of test, procedure or treatment on the individuals included in a CT and that are sent from a participating centre in the CT. It should be noted that all centres that include patients must be considered participating centres in the CT for all purposes and must appear in the application form for a CT. In this sense, the information that the sponsor must provide in Part II of the trial is as follows: Suitability of the external centre: If the tests are referred to an external provider centre that is part of the participating centre's health care network (for example, a centre that routinely refers patients to another centre for computed tomography (CT), densitometries, echocardiography, etc.), these services will be recorded as participants in the appropriateness document for the participating centre's facilities (Annex IV), specifying that they will be performed at a satellite centre. If the tests are referred to external centres specifically hired by the sponsor for the trial and which, therefore, ARE NOT part of the healthcare network of the participating centre, a specific Annex IV will be necessary for the satellite centre. The patient should be informed of the possibility of having to travel to other centres for to the study. This possibility should be mentioned on the patient information sheet and clinical history (PIL-IC). Given the variability of the studies or the possibility that the external centres will participate in carrying out the study, it is advisable to introduce the following sentence in all PIL-ICs: "It is possible that, throughout your participation in this study, some of the tests or visits need to be performed at a centre different to your usual one; ask your doctor for more information." Certificate of insurance policy: Insurance must cover the activities of the satellite centre and this must be clearly mentioned in the policy, except in cases where the external centre is a regular provider, forming part of the healthcare network of the participating centre. In addition, the sponsor must guarantee (without needing to notify CEIm) the following: Agreement/contract with the external centre to perform procedures within the clinical trial. Compliance with good clinical practices (GCP) for the external centre, which includes: Delegation of responsibilities of the activities that will be carried out at the satellite centre. GCP training for all the personnel involved in the trial. Training in the specific protocol of this trial, even when the satellite centre performs, for example, a CT. It is imperative that the staff know that they are performing a test that is part of a clinical trial. This would further imply that this centre should be included in trial monitoring. Traceability compliance for everything regarding the trial in the Researcher's File (during an inspection, information on what has been done in this centre, who has been involved, the delegates for these activities, etc., may be requested. A full clinical history would not be valid, rather only that which concerns the trial specifically). 31. If I include it once the clinical trial is already underway, how should I proceed? You must notify the CEIm: firstname.lastname@example.org. The CEIm will include notification at a follow-up meeting, but you can proceed with the satellite centre in accordance with what has been previously discussed. The CEIm will not give any approvals. In the event that any action is required at this meeting, the sponsor will be contacted. 32. There is a patient in the clinical trial that does not speak Spanish. Is it necessary to provide the translated patient information leaflets and informed consent (PIL-IC) to the CEIm? No, the sponsor is responsible for providing a reliable translation of the Patient information sheet and informed consent (PIL-IC) approved by the CEIm in the patient's mother tongue. These translations should not be sent to CEIm, unless an express request is made by the CEIm for some particular reason. 33. There is a patient in the clinical trial that does not speak Spanish, but understands English (despite English not being their mother tongue). Can a Patient information sheet and informed consent (PIL-IC) in English be signed? The patient should receive the Patient information sheet and informed consent (PIL-IC) in their mother tongue, as set forth in the current legislation. However, if the principal investigator performs an assessment and considers that the patient is able to understand and read that document in English, they may sign it in that language. The version of the PIL-IC in English must always contain the same information as the PIL-IC approved in Spanish by the CEIm. The principal investigator is responsible for performing the aforementioned assessment and must express this in writing in the patient's clinical history. 34. What safety information for a clinical trial should we notify to your CEIm? We should receive the safety notifications only for those studies for which we are the CEIm evaluator in Spain. If we are not, we should not receive them. You must submit: Development safety update report (DSUR). Suspected unexpected serious adverse reactions (SUSAR) that have taken place in Spain, the outcome of which have been death. Specific safety notifications for the clinical trial for which we are the CEIm evaluator (urgent safety measures, notifications related to any problem that has affected the safety of a patient, etc.). 35. A principal investigator is on medical leave. What should I do? There are 2 options: If, from the standpoint of a sponsor, you consider that during the medical leave, tasks can be delegated to a sub-researcher, it would not require a substantial modification to change the principal investigator. Only an email notification to the CEIm is required, to: email@example.com. The CEIm or the Technical Secretariat will not send any form of approval to the sponsor. It will be processed as a notification, and thus requires no evaluation. If, from the standpoint of a sponsor, you consider the trial will not be able to continue during the medical leave, it is recommended to make a substantial modification to change the principal investigator and present it to the CEIm for evaluation. 36. Do current regulations contain any article related to this procedure? As for the procedure of delegation of functions by the Principal Investigator (PI), this procedure is mentioned in the following regulations: Royal Decree 1090/2015 dated 4 December, regulating clinical trials with drugs, ethics committees for drug research and the Spanish registry of clinical trials. In article 41, point 5, it says: The principal investigator may delegate tasks to the research team members. This delegation does not exempt the investigator from being responsible for carrying out the trial in accordance with the current legislation. The researcher's responsibility delegation sheet for each clinical trial must state not only the participating personnel, but also the collaborating researchers to whom they have delegated the execution of certain function, as well as their functions and responsibilities. If there are changes, these must be reflected. Standards of Good Clinical Practice (CPMP/ICH/135/95). Point 4, section 4.1, subsection 4.1.5, states: The investigator shall file the list of duly qualified persons with significant trial-related obligations. There is no document specifically addressing the procedure to follow if a principal investigator is on medical leave. A principal investigator on maternity leave still has the valid, centre-linked contract, so he/she can exercise his/her responsibility even if he/she cannot perform all the tasks. For this reason, if you have collaborators who can perform these tasks, a change of principal investigator is not necessary during this period, since the study can be carried out. 37. Should the CEIm evaluate a study containing patient data collected from my practice? Yes, the CEIm must evaluate any study in which information or samples are collected from patients of the centre, even if they have been collected as part of clinical practice, since these samples or information will be used for research purposes, not healthcare. 38. Should the CEIm evaluate a questionnaire study aimed at hospital staff? Yes, since data will be collected from the workers at the centre. It will have to be presented as a research project in accordance with the requirements specified on our website. 39. Should the CEIm evaluate a clinical case that I want to publish? In principle, the CEIm need not evaluate clinical cases and, legally, it is not necessary to do so. However, should a journal explicitly request our approval, we would evaluate the case that you want to publish and issue a certificate stating that the study is ethically acceptable. 40. Should the CEIm evaluate a validation study of reagents or devices with biological samples from healthcare surplus? Our CEIm has agreed that there are two possible scenarios with respect to the transfer of samples for the validation of reagents or devices: Transfer of surplus biological samples for the validation of reagents or devices within the framework of a research project. This scenario requires the presentation of the research project report to justify this transfer and an application for approval from an internal or external clinical research ethics committee (CREC). Transfer of biological samples from health care surplus for the validation of reagents or devices under a specific agreement validated by the person in charge of the clinical service. The management of the Vall d'Hebron University Hospital (HUVH) and the management of the Vall d'Hebron Research Institute (VHIR), which does not require the CREC’s approval request since it is not a research project in of itself. In this scenario, the following conditions must be met: The scope of this proposal is the use of surplus health care samples for the validation of a device or reagent. Being health care surplus, the informed consent of patients for non-healthcare uses has not been previously obtained, and obtaining it would entail unreasonable effort. The use of these samples for such purposes is performed anonymously, and there is no possibility of identifying the patient again. The understanding and/or agreement between the parties must specify: That surplus samples from the healthcare process will be used, so that they do not entail any risk/inconvenience for the patient. That it is necessary to ensure that extraction/taking of samples from patients will not be carried out solely in order to have the necessary samples for the validation. That the samples and data will be anonymised so that it is not possible to establish a link between the samples and the patient's identity. That the samples will be used for the validations described in the present understanding/agreement, and not for other purposes. That the samples may not be transferable to third parties, and will not have any commercial value.