The objective of this ICH GCP Guideline is to provide a unified standard for the European. Union (EU), Japan and the United States to facilitate the mutual
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European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44 – 20) 74 18 85 75 Fax (44 – 20) 75 23 70 40 E – mail: mail@emea. eu.int http://www.emea.eu.int EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged July 2002 CPMP/ICH/135/95 ICH Topic E 6 (R1) Guideline for Good Clinical Practice Step 5 NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE (CPMP/ICH/135/95) TRANSMISSION TO CPMP July 1996 FINAL APPROVAL BY CPMP July 1996 DATE FOR COMING INTO OP ERATION January 1997 POST STEP ERRATA (linguistic minor corrections) July 2002
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© EMEA 2006 2 TABLE OF CONTENT INTRODUCTION .. .. .. . 5 1. GLOSSARY .. .. .. . 5 1.1 A DVERSE D RUG R EACTION (ADR) .. .. . 5 1.2 A DVERSE E VENT (AE) .. .. .. . 5 1.3 A MENDME NT ( TO THE PROTOCOL ) .. .. 5 1.4 A PPLICABLE R EGULATORY R EQUIREMENT ( S ) .. .. 5 1.5 A PPROVAL ( IN RELATION TO I NSTITUTIONAL R EVIEW B OARDS ) .. . 5 1.6 A UDIT .. .. .. .. 5 1.7 A UDIT C ERTIFICATE .. .. .. . 6 1.8 A UDIT R EPORT .. .. .. 6 1.9 A UDIT T RAIL .. .. .. 6 1.10 B LINDING /M ASKING .. .. .. . 6 1.11 C ASE R EPORT F ORM (CRF) .. .. . 6 1.12 C LINICAL T RIAL /S TUDY .. .. .. . 6 1.13 C LINICAL T RIAL /S TUDY R EPORT .. .. .. 6 1.14 C OMPARATOR (P RODUCT ) .. .. .. . 6 1.15 C OMPLIANCE ( IN RELATION TO TRIAL S ) .. .. . 6 1.16 C ONFIDENTIALITY .. .. .. . 6 1.17 C ONTRACT .. .. .. . 6 1.18 C OORDINATING C OMMITTEE .. .. .. 6 1.19 C OORDINATING I NVESTIGATOR .. .. . 7 1.20 C ONTRACT R ESEARCH O RGANIZATION (CRO) .. .. .. 7 1.21 D IRECT A CCESS .. .. .. .. 7 1.22 D OCUMENTATION .. .. .. .. 7 1.23 E SSENTIAL D OCUMENTS .. .. .. . 7 1.24 G OOD C LINICAL P RACTICE (GCP) .. .. 7 1.2 5 I NDEPENDENT D ATA – M ONITORING C OMMITTEE (IDMC) (D ATA AND S AFETY M ONITORING B OARD , M ONITORING C OMMITTEE , D ATA M ONITORING C OMMITTEE ) 7 1.26 I MPARTIAL W ITNESS .. .. .. 7 1.27 I NDEPENDENT E THICS C OMMITTEE (IEC) .. .. 7 1.28 I NFORMED C ONSENT .. .. .. 8 1.29 I NSPECTION .. .. .. .. 8 1.30 I NSTITUTION ( MEDICAL ) .. .. .. . 8 1.31 I NSTITUTIONAL R EVIEW B OARD (IRB) .. .. .. 8 1.32 I NTE RIM C LINICAL T RIAL /S TUDY R EPORT .. .. .. 8 1.33 I NVESTIGATIONAL P RODUCT .. .. .. 8 1.34 I NVESTIGATOR .. .. .. . 8 1.35 I NVESTIGATOR / I NSTITUTION .. .. . 8 1.36 I NVESTIGATOR ‘ S B ROCHURE .. .. 8 1.37 L EGALLY A CCEPTABLE R EPRESENTATIVE .. .. 8 1.38 M ONITORING .. .. .. 9 1.39 M ONITORING R EPORT .. .. .. .. 9 1.40 M ULTICENTRE T RIAL .. .. .. .. 9 1.41 N ONCLINICAL S TUDY .. .. .. .. 9 1.42 O PINION ( IN RELATION TO I NDEPENDENT E THICS C OMMITTEE ) .. 9 1.43 O RIGINAL M EDICAL R ECORD .. .. . 9 1.44 P ROTOCOL .. .. .. . 9 1.45 P ROTOCOL A MENDMENT .. .. .. 9
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© EMEA 2006 3 1.46 Q UALITY A SSURANCE (QA) .. .. 9 1.47 Q UALITY C ONTROL (QC) .. .. .. .. 9 1.48 R ANDOMIZATION .. .. .. .. 9 1.49 R EGULATORY A UTHORITIES .. .. 9 1.50 S ERIOUS A DVERSE E VENT (SAE) OR S ERIOUS A DVERSE D RUG R EACTION (S ERIOUS ADR) 9 1.51 S OURCE D ATA .. .. .. .. 10 1.52 S OURCE D OCUMENTS .. .. .. 10 1.53 S PONSOR .. .. .. . 10 1.54 S PONSOR – I NVESTIGATOR .. .. .. 10 1.55 S TANDARD O PERATING P ROCEDURES (SOP S ) .. .. 10 1.56 S UBINVESTIGATOR .. .. .. . 10 1.57 S UBJECT /T RIAL S UBJECT .. .. .. . 10 1.58 S UBJECT I DENTIFICATION C ODE .. .. . 10 1.59 T RIAL S ITE .. .. .. . 10 1.60 U NEXPECTED A DVERSE D RUG R EACTION .. .. . 10 1.61 V ULNERABLE S UBJECTS .. .. .. .. 11 1.62 W ELL – BEING ( OF THE TRIAL SUBJECT S ) .. .. .. 11 2. THE PRINCIPLES OF IC H GCP .. .. 11 3. INSTITUTIONAL REVIEW BO ARD/INDEPENDENT ETHI CS COMMITTEE (IRB/IEC) .. .. .. .. .. 12 3.1 R ESPONSIBILITIES .. .. .. 12 3.2 C OMPOSITION , F UNCTIONS AND O PERATIONS .. .. . 13 3.3 P ROCEDURES .. .. .. . 13 3.4 R ECORDS .. .. .. . 14 4. INVESTIGATOR .. .. .. . 14 4.1 I NVESTIGATOR ‘ S Q UALIFICATIONS AND A GREEMENTS .. .. 14 4.2 A DEQUATE R ESOURCES .. .. .. .. 15 4.3 M EDICAL C ARE OF T RIAL S UBJECTS .. .. 15 4.4 C OMMUNICATION WITH IRB/IEC .. .. .. 15 4.5 C OMPLIANCE WITH P ROTOCOL .. .. 16 4.6 I NVESTIGATIONAL P RODUCT ( S ) .. .. .. 16 4.7 R ANDOMIZATION P ROCEDURES AND U NBLINDING .. .. 17 4.8 I NFORMED C ONSE NT OF T RIAL S UBJECTS .. .. . 17 4.9 R ECORDS AND R EPORTS .. .. .. .. 20 4.10 P ROGRESS R EPORTS .. .. .. .. 20 4.11 S AFETY R EPORTING .. .. .. .. 20 4.12 P REMATURE T ERMINATION OR S USPENSION OF A T RIAL .. .. 21 4.13 F INAL R EPORT ( S ) BY I NVESTIGATOR .. .. 21 5. SPONSOR .. .. .. . 21 5.1 Q UALITY A SSURANCE AND Q UALITY C ONTROL .. 21 5 .2 C ONTRACT R ESEARCH O RGANIZATION (CRO) .. . 22 5.3 M EDICAL E XPERTISE .. .. .. . 22 5.4 T RIAL D ESIGN .. .. .. .. 22 5.5 T RIAL M ANAGEMENT , D ATA H ANDLING , AND R ECORD K EEPING .. 22 5.6 I NVESTIGATOR S ELECTION .. .. 24 5.7 A LLOCATION OF R ESPONSIBILITIES .. .. .. 24 5.8 C OMPENSATION TO S UBJECTS AND I NVESTIGATORS .. .. 24 5.9 F INANCING .. .. .. . 24 5.10 N OTIFICATION /S UBMISSION TO R EGULATORY A UTHORITY ( IES ) .. .. 24
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© EMEA 2006 4 5.11 C ONFIRMATION OF R EVIEW BY IRB/IEC .. .. 25 5.12 I NFORMATION ON I NVESTIGATIONAL P RODUCT ( S ) .. .. 25 5.13 M ANUFACTURING , P ACKAGING , L ABELLING , AND C ODING I NVESTIGATIONAL P RODUCT ( S ) .. .. .. .. 25 5.14 S UPPLYING AND H ANDLING I NVESTIGATIONAL P RODUCT ( S ) .. . 26 5.15 R ECORD A CCESS .. .. .. . 26 5.16 S AFETY I NFORMATION .. .. .. .. 27 5.17 A DVERSE D RUG R EACTION R EPORTING .. .. . 27 5.18 M ONITORING .. .. .. . 27 5.19 A UDIT .. .. .. 29 5.20 N ONCOMPLIANCE .. .. .. 30 5.21 P REMATURE T ERMINATION OR S USPENSION OF A T RIAL .. .. 30 5.22 C LINICAL T RIAL /S TUDY R EPORTS .. .. . 30 5.23 M ULTICENTRE T RIALS .. .. .. .. 30 6. CLINICAL TRIAL PROTO COL AND PROTOCOL AME NDMENT(S) . 31 6.1 G ENERAL I NFORMATION .. .. .. .. 31 6.2 B ACKGROUND I NFORMATION .. .. .. 31 6.3 T RI AL O BJECTIVES AND P URPOSE .. .. . 31 6.4 T RIAL D ESIGN .. .. .. .. 32 6.5 S ELECTION AND W ITHDRAWAL OF S UBJECTS .. .. .. 32 6.6 T REATMENT OF S UBJECTS .. .. . 32 6.7 A SSESSMENT OF E FFICACY .. .. 33 6.8 A SSESSMENT OF S AFETY .. .. .. . 33 6.9 S TATISTICS .. .. .. . 33 6.10 D IRECT A CCESS TO S OURCE D ATA /D OCUMENTS .. . 33 6.11 Q UALIT Y C ONTROL AND Q UALITY A SSURANCE .. 33 6.12 E THICS .. .. .. .. 33 6.13 D ATA H ANDLING AND R ECORD K EEPING .. .. .. 34 6.14 F INANCING AND I NSURANCE .. .. 34 6.15 P UBLICATION P OLICY .. .. .. 34 6.16 S UPPLEMENTS .. .. .. 34 7. INVESTIGATORÍS BROCH URE .. .. 34 7.1 I NTRODUCTION .. .. .. . 34 7.2 G ENERAL C ONSIDERATIONS .. .. . 35 7.3 C ONTENTS OF THE I NVESTIGATORÍS B ROCHURE .. .. 35 7.5 APPENDIX 2: .. .. .. .. 38 8. E SSENTIAL DOCUMENTS F OR THE CONDUCT OF A CLINICAL TRIAL 39 8.1 I NTRODUCTION .. .. .. . 39 8.2 B EFORE THE C LINICAL P HASE OF THE T RIAL C OMMENC ES .. . 40 8.3 D URING THE C LINICAL C ONDUCT OF THE T RIAL .. .. 44 8.4 A FTER C OMPLETION OR T ERMINATION OF THE T RIAL .. 48
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© EMEA 2006 5 INTRODUCTION Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard prov ides public assurance that the rights, safety and well – being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. The guideline was developed with consideration o f the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO). This guideline should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities. The principles established in this guideline may also be applied to other clinical investigations that may have an impact on the safety and well – being of human subjects. 1. GLOSSARY 1.1 A dverse Drug Reaction (ADR) In the pre – approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any do se should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out. R egarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH Guidelin e for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). 1.2 Adverse Event (AE) Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not neces sarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigat ional) product, whether or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). 1.3 Amendment (to the protocol) See Protocol Amendment. 1.4 Applicable Regulatory Requirement(s) Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products. 1.5 Approval (in relation to Institutional Review Boards) The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements. 1.6 Audit A systematic and independent examination of tr ial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded,
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© EMEA 2006 6 analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Cl inical Practice (GCP), and the applicable regulatory requirement(s). 1.7 Audit Certificate A declaration of confirmation by the auditor that an audit has taken place. 1.8 Audit Report A written evaluation by the sponsor’s auditor of the results of the au dit. 1.9 Audit Trail Documentation that allows reconstruction of the course of events. 1.10 Blinding/Masking A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single – blinding usually refers to the subj ect(s) being unaware, and double – blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). 1.11 Case Report Form (CRF) A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. 1.12 Clinical Trial/Study Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharma codynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertain ing its safety and/or efficacy. The terms clinical trial and clinical study are synonymous. 1.13 Clinical Trial/Study Report A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report (see the ICH Guideline for Structure and Content of Clinical Study Reports). 1.14 Comparator (Product) An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. 1.15 Compliance (in relation to trials) Adherence to all the trial – related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements. 1 .16 Confidentiality Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity. 1.17 Contract A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract. 1.18 Coordinating Committee A committee that a sponsor may organize to coordinate the co nduct of a multicentre trial.
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© EMEA 2006 8 1.28 Informed Consent A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed o f all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form. 1.29 Inspection The act by a regulatory authority(ies) of conducting an of ficial review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organizationís (C ROís) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). 1.30 Institution (medical) Any public or private entity or agency or medical or dental facility where clinical trials are conducted. 1.31 Institutional Rev iew Board (IRB) An independent body constituted of medical, scientific, and non – scientific members, whose responsibility is to ensure the protection of the rights, safety and well – being of human subjects involved in a trial by, among other things, reviewin g, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. 1.32 Interim Clinical Trial/Study Report A report of intermediat e results and their evaluation based on analyses performed during the course of a trial. 1.33 Investigational Product A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product wit h a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. 1.34 Investigator A person re sponsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. See also Subinvestigator . 1.35 Investigator / Institution An expression meaning “the investigator and/or institution, where required by the applicable regulatory requirements”. 1.36 Investigator’s Brochure A compilation of the clinical and nonclinical data on the investigation al product(s) which is relevant to the study of the investigational product(s) in human subjects (see 7. Investigatorís Brochure). 1.37 Legally Acceptable Representative An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial.
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© EMEA 2006 9 1.38 Monitoring The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). 1.39 Monitoring Report A written report from the monitor to the sponsor after each site visit and/or other trial – related communication acco rding to the sponsorís SOPs. 1.40 Multicentre Trial A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator. 1.41 Nonclinical Study Biomedical studies not performed on human subjects. 1.42 Opinion (in relation to Independent Ethics Committee) The judgement and/or the advice provided by an Independent Ethics Committee (IEC). 1.43 Original Medical Record See Source Documents. 1.44 Protocol A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments. 1.45 Protocol Amendment A written description of a change(s) to or formal clarification of a protocol. 1.46 Quality Assurance (QA) All those planned and systematic actions that a re established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s). 1.47 Quality Control (QC) The operational t echniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial – related activities have been fulfilled. 1.48 Randomization The process of assigning trial subjects to treatment or control gro ups using an element of chance to determine the assignments in order to reduce bias. 1.49 Regulatory Authorities Bodies having the power to regulate. In the ICH GCP guideline the expression Regulatory Authorities includes the authorities that review subm itted clinical data and those that conduct inspections (see 1.29). These bodies are sometimes referred to as competent authorities. 1.50 Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR) Any untoward medical occurrence that at any dose: results in death, is life – threatening, requires inpatient hospitalization or prolongation of existing hospitalization,
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© EMEA 2006 10 results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see the ICH Guideline for C linical Safety Data Management: Definitions and Standards for Expedited Reporting). 1.51 Source Data All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial n ecessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies). 1.52 Source Documents Original documents, data, and records (e.g., hospital records, clinical and office cha rts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic n egatives, microfilm or magnetic media, x – rays, subject files, and records kept at the pharmacy, at the laboratories and at medico – technical departments involved in the clinical trial). 1.53 Sponsor An individual, company, institution, or organization whic h takes responsibility for the initiation, management, and/or financing of a clinical trial. 1.54 Sponsor – Investigator An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investiga tional product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor – investigator include both those of a s ponsor and those of an investigator. 1.55 Standard Operating Procedures (SOPs) Detailed, written instructions to achieve uniformity of the performance of a specific function. 1.56 Subinvestigator Any individual member of the clinical trial team designate d and supervised by the investigator at a trial site to perform critical trial – related procedures and/or to make important trial – related decisions (e.g., associates, residents, research fellows). See also Investigator. 1.57 Subject/Trial Subject An indivi dual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control. 1.58 Subject Identification Code A unique identifier assigned by the investigator to each trial subject to protect the subject’s identity a nd used in lieu of the subject’s name when the investigator reports adverse events and/or other trial related data. 1.59 Trial Site The location(s) where trial – related activities are actually conducted. 1.60 Unexpected Adverse Drug Reaction An adverse re action, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational product or package
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© EMEA 2006 11 insert/summary of product characteristics for an approved product) (see th e ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting). 1.61 Vulnerable Subjects Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justifie d or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nu rsing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing home s, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. 1.62 Well – being (of the trial subjects) The physical and mental integrity o f the subjects participating in a clinical trial. 2. THE PRINCIPLES OF ICH GCP 2.1 Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and t he applicable regulatory requirement(s). 2.2 Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only i f the anticipated benefits justify the risks. 2.3 The rights, safety, and well – being of the trial subjects are the most important considerations and should prevail over interests of science and society. 2.4 The available nonclinical and clinical informat ion on an investigational product should be adequate to support the proposed clinical trial. 2.5 Clinical trials should be scientifically sound, and described in a clear, detailed protocol. 2.6 A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion. 2.7 The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified p hysician or, when appropriate, of a qualified dentist. 2.8 Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s). 2.9 Freely given informed consent should be obt ained from every subject prior to clinical trial participation. 2.10 All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
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