ДСТУ EN ISO 14155:2022 Клінічні дослідження медичних виробів для людей. Належна клінічна практика (EN ISO 14155:2020, IDT; ISO 14155:2020, IDT)



ДСТУ EN ISO 14155:2022
(EN ISO 14155:2020, IDT; ISO 14155:2020, IDT)

Клінічні дослідження медичних виробів для людей. Належна клінічна практика

 
   
 
 
     
Не є офіційним виданням.
Офіційне видання розповсюджує національний орган стандартизації
(ДП «УкрНДНЦ» http://uas.gov.ua)

Contents

Foreword

1 Scope

2 Normative references

3 Terms and definitions

4 Summary of good clinical practice (GCP) principles

5 Ethical considerations

5.1 General

5.2 Improper influence or inducement

5.3 Compensation and additional health care

5.4 Registration in publicly accessible database

5.5 Responsibilities

5.6 Communication with the ethics committee (EC)

5.7 Vulnerable populations

5.8 Informed consent

6 Clinical investigation planning

6.1 General

6.2 Risk management

6.3 Justification for the design of the clinical investigation

6.4 Clinical investigation plan (CIP)

6.5 Investigator's brochure (IB)

6.6 Case report forms (CRFs)

6.7 Monitoring plan

6.8 Investigation site selection

6.9 Agreement(s)

6.10 Labelling

6.11 Data monitoring committee (DMC)

7 Clinical investigation conduct

7.1 General

7.2 Investigation site initiation

7.3 Investigation site monitoring

7.4 Adverse events and device deficiencies

7.5 Clinical investigation documents and documentation

7.6 Additional members of the investigation site team

7.7 Subject privacy and confidentiality of data

7.8 Document and data control

7.9 Investigational device accountability

7.10 Accounting for subjects

7.11 Auditing

8 Suspension, termination, and close-out of the clinical investigation

8.1 Completion of the clinical investigation

8.2 Suspension or premature termination of the clinical investigation

8.3 Routine close-out

8.4 Clinical investigation report

8.5 Risk assessment and conclusions

8.6 Document retention

9 Resnonsibilities of the sponsor

9.1 Clinical quality management

9.2 Clinical investigation olanning and conduct

9.2.1 Selection and training of clinical personnel

9.2.2 Preparation of documents and materials

9.2.3 Conduct of clinical investigation

9.2.4 Monitoring

9.2.5 Safety evaluation and reporting

9.2.6 Clinical investigation close-out

9.3 Outsourcing of duties and functions

9.4 Communication with regulatory authorities

10 Resnonsibilities of the nrincinal investigator

10.1 General

10.2 Qualification of the principal investigator

10.3 Qualification of investigation site

10.4 Communication with the EC

10.5 Informed consent process

10.6 Compliance with the CIP

10.7 Medical care of subjects

10.8 Safety renorting

Annex A (normative) Clinical investigation plan (CIP)

Annex В (normative) Investigator's brochure (IB)

Annex C (informative) Case report forms (CRFs)

Annex D (normative) Clinical investigation report

Annex E (informative) Essential clinical investigation documents

Annex F finformativel Adverse event categorization

Annex G (informative) EC responsibilities

Annex H (informative) Application of ISO 14971 to clinical investigations

Annex I (informative) Clinical development stages

Annex I (informative) Clinical investigation audits

Bibliography