Evaluation requirements

Definition

The clinical trials, according to the Royal Decree 1090/2015, are the clinical studies that meet any of the following conditions:

• The trial subject is assigned in advance to a particular therapeutic strategy, which is not part of the usual clinical practice of the Member State involved.
• The decision to prescribe medicines on research is made in conjunction with the decision to enroll the subject in the clinical trial.
• Diagnostic or follow-up procedures are applied to test subjects that go beyond standard clinical practice.

Normative

The clinical trials, according to the Royal Decree 1090/2015, are the clinical studies that meet any of the following conditions:

• The trial subject is assigned in advance to a particular therapeutic strategy, which is not part of the usual clinical practice of the Member State involved.
• The decision to prescribe medicines on research is made in conjunction with the decision to enroll the subject in the clinical trial.
• Diagnostic or follow-up procedures are applied to test subjects that go beyond standard clinical practice.

Evaluation requirements by the CEIm

The documents that must be presented for the initial evaluation of a clinical trial with mediciness are indicated in the next link: “AEMPS instructions to make clinical trials in Spain”. On the documents of the clinical trials there are two different parts, part I (documents to send to the AEMPS and the CEIm, and documents to send only to the AEMPS) and part II (documents to send only to CEIm).

The promoter must present the following documents trough the portal Clinical Trials Information System (link CTIS).

• Initial evaluation
• Substantial modification (amendment)

1. Presentation letter of the substantial modification.
2. Substantial modification solicitude form.
3. Summary and change justifications.
4. Comparative table with previous text ─ new text.
5. New version of the documents to be modified with “track changes”
6. New version of the documents to be modified in a fair copy.
7. New documents.
8. Documents supporting the changes, if applicable.
9. Billing data for payment of the assessment fee or fee waiver request.

Those clinical trials initiated under the previous regulations and submitted on the Clinical Trials Portal may submit substantial modifications under the same portal until 2025.

The management of the contract will be processed in parallel to the application by the CEIm of the Hospital Clínico Universitario de València; for this purpose, please contact the Contracts Management Area of the Foundation at the following address ensayosclinicos@incliva.es.

Favorable opinion of another CEIm

According with the provisions of Article 17 of Royal Decree 1090/2015, all clinical trials with medicinal products will require the favorable opinion of a CEIm accredited in Spain. Said opinion will be unique, binding and recognized throughout the national territory. Therefore, in these cases, the CEIm recognizes the approval and the study will not be re-evaluated. The documentation to be provided by the promoter to the CEIm of the HCUV (ceic_hcv@gva.es) is:

• Suitability of the facilities according to the model published by the AEMPS.
• Abbreviated curriculum vitae (CV) of the principal investigator.
• Declaration of conflict of interest, if not included in the CV.
• Training in good clinical practice, if not included in the CV.

The management of the contract will be processed in parallel to the application by the CEIm of the Hospital Clínico Universitario de València; for this purpose, please contact the Contract Management Area of the Foundation at ensayosclinicos@incliva.es.

Documents models

• Patients’ information sheet
• Economic report
• Proceedings and recruitment material

Definition

A medical device is any instrument, device, equipment, software, implant, reagent, material or other article intended by the manufacturer to be used on persons, separately or in combination, for specific medical purposes.

Normative

The Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices establishes the general requirements in relation to the clinical research with medical devices on chapter VI and the Annexes XIV and XV thereof. The Regulation (EU) 2022/2346 of the commission of December 1, 2022 establishes the common specification for the groups of devices without intended medical purpose listed in Annex XVI of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices.

Favorable opinion emitted by CEIm of the national territory would be only and linked.

Types of medical devices

On clinical researches with medical devices there are different situations listed on the AEMPS website:

1. Medical devices without CE marking (article 62 of the Regulation).
2. Medical devices with CE marking, but not used under authorized and usual conditions of use.

Medical devices with CE marking following their instructions for use and within the intended purpose (Research Project).

Evaluation requirements by the CEIm

1. Clinical research with medical devices without a CE market or with a CE market, but outside the scope of their intended purpose: the following documents must be submitted for initial evaluation or substantial modifications:

• Initial evaluation
• Substantial modification (amendment): the promoter must present the following documents:

1. Presentation letter of the substantial modification.
2. Summary and justification of the changes.
3. Comparative table with previous text versus new text.
4. New version of the documents to be modified with “track changes”
5. New version of the documents to be modified in a fair copy.
6. New documents, if applicable.
7. Documents supporting the changes.
8. Consequences of the modification.
9. Billing details for payment of evaluation fee or fee exemption request.

 

2. Clinical research with medical devices with a CE market following the instructions use and inside the scope of their intended purpose: for the initial evaluation or substantial modifications, the following documents must be presented:

 

• Initial evaluation
• Substantial modification (amendment): the promoter must present the following documents:

1. Presentation letter of the substantial modification.
2. Summary and justification of the changes.
3. Comparative table with previous text versus new text.
4. New version of the documents to be modified with “track changes”
5. New version of the documents to be modified in a fair copy.
6. New documents, if applicable.
7. Documents supporting the changes.
8. Consequences of the modification.
9. Billing details for payment of evaluation fee or fee exemption request.

The management of the contract will be processed in parallel to the application by the CEIm of the Hospital Clínico Universitario de València; and for this purpose, they should contact the Contracts Management Area of the Foundation at the address ensayosclinicos@incliva.es.

 

Documents models

• Patients’ information sheet
• Economic report
• Proceedings and recruitment material

Definition

An observational study with medicines is any research involving the collection of individual data relating to the health of persons, provided that it does not meet any of the conditions required to be considered a clinical trial (established in Article 2.1.i) of Royal Decree 1090/2015 and that it is conducted for any of the following purposes:

• Determine the beneficial effects of medicines, as well as their modifying factors, including the patients’ perspective, and their relationship to the resources used to achieve them.
• Identify, characterize or quantify adverse medicines reactions and other patient safety risks associated with the use of medicines, including potential risk factors or effect modifiers, and measure the effectiveness of risk management measures.
• Obtain information on medicines utilization patterns in the population.
• Observational studies with medicines are intended to complement known medicines information without interfering with routine clinical practice.

The observational studies with medicines are intended to complement the known information on the medicines without interfering with routine clinical practice.

Normative

The Royal Decree 957/2020, November 3, which regulates observational studies with medicinal products for human use, establishes the conditions for the evaluation, conduct and follow-up of observational studies with medicinal products for human use carried out in Spain.

Favorable opinion emitted by CEIm of the national territory would be only and linked.

Evaluation requirements by the CEIm

The instructions of the Spanish Agency of Medicines and Health Products (AEMPS) for conducting observational studies with medicines can be found at the following link: AEMPS. In the case of prospective follow-up observational studies, authorization must be requested from the Autonomous Committee for Prospective Observational Studies of Medicines of the Valencian Community (CAEPO).

For the initial evaluation or substantial modifications, the following documents must be presented:

• Initial evaluation
• Substantial modification (amendment): the promoter must present the following documents:

1. Presentation letter of the substantial modification.
2. Summary and justification of the changes.
3. Comparative table with previous text versus new text.
4. New version of the documents to be modified with “track changes”
5. New version of the documents to be modified in a fair copy.
6. New documents, if applicable.
7. Documents supporting the changes.
8. Consequences of the modification.
9. Billing details for payment of evaluation fee or fee exemption request.

The management of the contract will be processed in parallel to the application by the CEIm of the Hospital Clínico Universitario de València; and for this purpose, they should contact the Contracts Management Area of the Foundation at the address ensayosclinicos@incliva.es.

 Documents models

• Patients’ information sheet
• Economic report

Definition

A research project is any biomedical research involving interventions on human beings, the performance of genetic analyses, the processing of genetic data of a personal nature or of biological samples of human origin.

Normative

According to Law 14/2007, of July 3, 2007, on Biomedical Research, the authorization and development of any research project on human beings or their biological material will require the prior and mandatory favorable report of the Research Ethics Committee. The law is built on the principles of the integrity of persons and the protection of the dignity and identity of the human being in any biomedical research. The same obligation is provided for in the Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantee of digital rights) and in the Implementing Regulation (EU) 2022/868 of the European Parliament and of the Council of 30 May 2022 on European data governance.

Order SSI/81/2017 of January 19 establishes the basic guidelines for action aimed at guaranteeing the patient’s right to dignity and privacy when attended by professionals undergoing specialized training in Health Sciences (residents in training). The following document contains some points of particular relevance of this Order SSI/81/2017: protocol of confidentiality of academic studies.

Evaluation requirements by the CEIm

For the initial evaluation or substantial modifications, the following documents must be presented:

• Initial evaluation
• Substantial modification (amendment): the following documentation must be submitted at the email ceic_hcv@gva.es

1. A presentation letter that includes the summary and the changes justification.
2. New version of the documents to be modified with “track changes”.
3. New version of the documents to be modified in a fair copy.
4. New documents, if necessary.

Documents models:

• Submission of documentation (“Dossier”)
• Confidentiality agreement for residents
• Confidentiality agreement for students
• Project template
• Patient information sheet
• Informed consent extension request template
• Principal Investigator’s commitment and Service Chief’s authorization
• Principal Investigator’s report
• Approval from involved departments
• Project economic report
• Confidentiality agreement for external researchers of the Regional Ministry for Health of the Valencian Government.

According with the regulations of the University of Valencia, the end-of-degree project (TFG)  in the modality of research work involving patients must have a favorable report from the CEIC or CEIm of the Center where the research is carried out.

If the research topic of the Master’s Thesis (TFM) or Doctoral Thesis is related to animal experimentation, biosafety or human research, even if it is only the use of medical records, biological samples of human origin or biological agents, the evaluation by the CEIC or CEIm of the Center where the research is carried out must be requested prior to its realization (www.uv.es/uvetica).

Normative

Order SSI/81/2017 of January 19 establishes the basic guidelines for action aimed at guaranteeing the patient’s right to dignity and privacy when attended in the presence of students of degrees related to health sciences (students) and when attended by professionals undergoing specialized training in Health Sciences (residents in training). The following document contains some points of particular relevance of this Order SSI/81/2017: protocol of confidentiality of academic studies.

 

Evaluation requirements by the CEIm

For the initial evaluation or substantial modifications, the following documents must be presented:

• Initial evaluation
• Substantial modification (amendment): the following documentation must be submitted at the email ceic_hcv@gva.es

1. A presentation letter that includes the summary and the changes justification.
2. New version of the documents to be modified with “track changes”.
3. New version of the documents to be modified in a fair copy.
4. New documents, if necessary.

Documents models

• Submission of documentation (“Dossier”)
• Confidentiality agreement for residents
• Confidentiality agreement for students
• Project template
• Patient information sheet
• Informed consent extension request template
• Principal Investigator’s commitment and Service Chief’s authorization
• Principal Investigator’s report
• Approval from involved departments
• Project economic report
• Confidentiality agreement for external researchers of the Regional Ministry for Health of the Valencian Government

Normative

According to the latest amendment of September 05, 2022 of Law 14/2007, of July 3, on Biomedical Research, the Research Ethics Committees are responsible for the authorization of research projects with human pluripotent cells obtained by cellular reprogramming when they involve:

1. a) Its generation through the use of non-embryonic somatic cells from healthy or diseased donors and their characterization, including the formation of teratomas.
2. b) Its generation from registered cells, of human origin, non-embryonic, coming from biobanks or of commercial origin.
3. c) Its use or that of its derivatives, coming from biobanks or from researchers in other countries for in vitro research, except those that have reproductive purposes, gamete production and formation of interspecies primary chimeras.

Evaluation requirements by the CEIm

For the initial evaluation or substantial modifications of research projects involving Induced Pluripotent Stem Cells (iPSC) the following documents must be presented:

• Initial evaluation
• Substantial modification (amendment): the following documentation must be submitted at the email (ceic_hcv@gva.es)

1. A presentation letter that includes the summary and the changes justification.
2. New version of the documents to be modified with “track changes”.
3. New version of the documents to be modified in a fair copy.
4. New documents, if necessary.

Documents models

The Institute of Health Carlos III has drafted a document with the indications for the drafting of the Participant Information Sheet and the Informed Consent for research projects involving the generation of iPSCs.

• Patient information sheet