The execution of this project will be performed inside hospital facilities and in the frame of the usual clinical and research practice. Therefore liability issues and obligations related to the safety and security of patients and operators involved in the study execution are already covered by the relevant institutions. The national laws regarding liability in healthcare will also apply. In general the follwing directives will be considered:
- Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
- EN ISO 14155-1 (2005) “Clinical investigation of medical devices for human subject. General requirements” defining the procedures for the execution and management of medical experiences and for the safety of human users, which also indicates responsibilities of sponsors, producers, experimenters and monitoring personnel, content of documents including informed consent and the role of Ethical Committees;
- EN ISO 14155-2 (2004) “Clinical investigation of medical devices for human subject. Clinical investigation plan” defining the procedures to prepare the plans devoted to the evaluation of medical devices;
- EN ISO 14971 (2007) – “Application of Risk management to medical devices” addressing risk identification, assessment and acceptability in the use of medical devices.
For all general aspects the project will adopt WHO policies and recommendations concerning the application of eHealth in Europe.
Protection of individuals/patients enrolled in the trial
The responsible Principal Investigator of each participating center will ensure that this study is conducted in compliance with the protocol, following the instructions and procedures described in it, adhering to the principles of Good Clinical Practice and with current local legislation and in accordance with: ICH Harmonized Tripartite Guidelines for Good Clinical Practice, Directive 2001/20/EEC of the European Parliament and of the Council, Declaration of Helsinki concerning medical research in humans (Helsinki 1964, amended Tokyo 1975, Venice 1983, Hong Kong 1989, Somerset West 1996 and Edinburgh).
Ethics and regulatory review
This project will be initiated only after all required legal documentation has been reviewed and approved by the responsible independent ethics committee (IEC) and competent authority (CA) of the center according to all applying national and international regulations. Prior to patient participation in the trial, written informed consent must be obtained from each patient (or the patient’s legally accepted representative) according to ICH GCP and to the regulatory and legal requirements of the participating Country. Each signature must be personally dated by each signatory and the informed consent and any additional patient information form retained by the investigator as part of the trial records. A signed copy of the informed consent and any additional patient information must be given to each patient or the patient’s legally accepted representative.
An unconditional prerequisite for a subject participating in the study is his/her written informed consent. Adequate information must therefore be given to the patient by the investigator before informed consent is obtained. A person designated by the investigator may give the information, if permitted by local regulations. A patient information sheet in the local language and prepared in accordance with the ICH Note for Guidance on Good Clinical Practice (ICH, Topic E6, 1995) will be provided for the purpose of obtaining informed consent. In addition to this written information, the investigator or the designate will inform the patient verbally. In doing so, the wording used will be chosen so that the information can be fully and readily understood by laypersons.
The patient information sheet will be revised whenever important new information becomes available that may be relevant to the consent of patients.
Confidentiality and data protection
Patients’ names will not be recorded. A sequential identification number will be automatically attributed to each patient registered in the trial. This number will identify the patient and must be included on all CRFs and the documentation accompanying a biological specimen. All samples are labeled with a unique ID number that is recorded combined only with the sequential identification number of the patient, the type of material collected, and the date of sampling. Investigators must guarantee that all personnel involved in this study will respect the confidentiality of any information concerning the trial subject. All parties involved in this clinical trial will maintain the strict confidentiality to assure that neither the person nor the family privacy of the patient participating in the trial is violated; appropriate measures shall be taken to avoid the access of non-authorized persons to the trial data. The processing of the personal data of patients taking part in the trial shall comply with local law on the privacy and with the European Directive on the privacy of data (95/46/EC).
Ethics Committee or Institutional Review Board
Prior to commencement of the project, the study protocol will be submitted together with its associated documents (patient information sheet, consent form, final protocol and synopsis) to the relevant EC for their approval. The study will only commence when written approval has been obtained, documenting the date of the meeting, constitution of the committee and voting members present at the meeting as well as clearly identifying the trial, protocol version, and consent documents reviewed. Any amendments to the protocol will be submitted to the EC. If a protocol amendment requires a change to the Informed Consent Form the centers’ Ethics Committee are to approve the revised ICF before the revised form is used. If local regulations require, any administrative change will be communicated to or approved by each Ethics Committee.
Given the retrospective nature of the project, it is expected that the majority of patients eligible to the study may be deceased at time of data collection. Hence, the investigator will obtain informed consent from the patient or from next of kin/legal representative as appropriate, according to local regulations, unless a consent waiver is applicable.
It is to be noted that for patients who are deceased, consent from next of kin/legal representative applies to retrieval and analysis of archival tumor samples, data collection, processing and disclosure as described above. Subjects or next of kin/legal representative must also be notified that they are free to discontinue from the study at any time. The subjects or next of kin/legal representative should be given the opportunity to ask questions and allowed time to consider the information provided.