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SOP_04-Site Research Team= Competency, Knowledge and Training)-Procedures

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SOP04EN02

Title

Code No. of Pages

Site Research Team: Competence, Knowledge and Training

SOP-04 7

History of Validated Versions

Date Version Pages dd/mmm/yyyy

Description of Change

History of SOP Implementation

Version Date dd/mmm/yyyy Version

Approval of Site SOP Date dd/mmm/yyyy Version Date dd/mmm/yyyy

Signature

dd/mmm/yyyy

Date

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SOP 04 –Site Research Team: Competence, Knowledge and Training

SOP04EN02

Table of contents

1. Policy 2. Objective

3. Site Responsibilities

3.1. 3.2.

Director of the Research Centre

Sponsor-Investigator or Investigator / Qualified Investigator

3.3. Person Responsible for the Site SOPs 4. Procedures

4.1.

Competence and Knowledge - Curriculum Vitae 4.2. Training 5. References 6. Appendices

Appendix 1 – Instructions Specific to the Site Appendix 2 – Training Documentation

1. Policy

Within the framework of the Declaration of Helsinki and in accordance with the principles

inherent in Good Clinical Practice (GCP) of the International Conference on Harmonisation (ICH), this standard operating procedure (SOP) describes the competency and training requirements of personnel involved in conducting a clinical study.

This SOP concerns all institutional personnel working in clinical research and should be followed by all those working on clinical studies involving human subjects.

2. Objective

The objective of this operating procedure is to inform all members of the research team of the requirements concerning competence, knowledge and training. This SOP outlines how these requirements are to be documented.

3. Site Responsibilities

3.1 The Director of the Research Centre, or delegate, is responsible for:

3.1.1 Approving or updating the site SOP that will be used in the institution according to

internal institutional validation procedures;

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3.1.2 Informing members of the Ethics Committee that this site SOP will be implemented

within the institution; 3.1.3 Implementing and managing this site SOP within the institution;

3.2 The Sponsor-Investigator or Investigator/Qualified Investigator is responsible for:

3.2.1 Ensuring that, during the clinical study, the research team, which will be under

his/her supervision will comply with this site SOP.

3.3 Under the supervision of the Research Centre Director or his delegate, the person

responsible for site SOPs should:

3.3.1 At the time of implementation of each SOP ensure that clinical study personnel at the

institution are trained in procedures and comply with this SOP.

3.3.2

In the event that an SOP is modified, provide training for institutional clinical study personnel regarding the change(s) and ensure their compliance with any changes.

4. Procedures

4.1 Competence and knowledge – Curriculum vitae

Within the framework of clinical studies with drugs:

It is the duty of the physician in medical research to protect the life, health, privacy and dignity of the human subject, Declaration of Helsinki, B10, 2002.

Medical research involving human subjects should conform to generally accepted scientific principles. It should be based on a thorough knowledge of the scientific literature, other relevant sources of information and on adequate laboratory and, where appropriate, animal experimentation, Declaration of Helsinki, B11, 2002.

In agreement with the Declaration of Helsinki, all medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given consent, Declaration of Helsinki, B15, 2002.

Within the framework or clinical studies without drugs:

It is the duty of the researcher in medical research to protect the life, health, privacy and dignity of the human subject.

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All medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent researcher. The responsibility for the human subject must always rest with a professionally qualified person and never rest on the subject of the research, even though the subject has given consent. In agreement with ICH principle 2.8, each individual involved in conducting a study should be qualified by education, training and experience to perform his or her respective tasks. In agreement with ICH principle 4.1.1, the investigator should be qualified by education, training, and experience to assume responsibility for the proper conduct of the study, meet all the qualifications specified by the applicable regulatory requirements and provide evidence of such qualifications through up-to-date curriculum vitae and other relevant documentation requested by the sponsor/sponsor-investigator, the Ethics Committee, or the regulatory authorities.

In agreement with ICH principle 4.1.5, the investigator should maintain a list of appropriately qualified persons to whom he has delegated significant study related tasks. 4.1.1 The investigator/qualified investigator, subinvestigators (ICH 8.2.10) and every other

person to whom the investigator/qualified investigator has delegated related study tasks listed in “Research Team: Roles definition, Responsibilities and Tasks Delegation”, SOP 03, should provide a complete curriculum vitae, dated and signed, available for submission. It is suggested that the curriculum vitae be updated every 2 years. 4.1.2 The submitted curriculum vitae should be kept with the essential documents and be

available for verification or inspection. 4.1.3 The curriculum vitae should be up-to-date and include a record of employment,

education, experience, professional qualifications, training received including clinical study , e.g. GCP, seminars attended, involvement in clinical studies and, if applicable, teaching experience and publications participation.

While getting ready for the study, the sponsor or sponsor-investigator may often require a proof of the right to practice medicine from the investigator/qualified investigator (license). If applicable, this license may be required annually.

4.2 Training

In agreement with ICH principles, it is required that:

- the investigator know and comply with GCP and regulatory requirements ICH 4.1.3;

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- the investigator be able to rely on an adequate number of qualified employees and adequate facilities for the foreseen duration of the clinical study, in order to conduct it in a safe and appropriate manner, ICH 4.2.3;

- the investigator ensures that all persons assisting with the study are adequately informed about the protocol, investigational product(s), biological products, medical devices or radiopharmaceuticals, and study related tasks and functions, ICH 4.2.4:

4.2.1 The investigator/qualified investigator ensures that training of the study team in GCP

of ICH is documented; 4.2.2 Training documentation should be kept with the essential study documents and be

available for verification or inspection; 4.2.3 All training related to qualification of research team members involved in the

conduct of clinical studies should be documented and kept with the essential study documents; 4.2.4 Training documentation should include the title of the training, duration, participant

name and training date, the person or organization who provided the training and a summary of the training. The training documentation can be filed individually for every participant or for the whole group. To document a whole group training, an example of form is presented in Appendix 2.

5. References

Health Canada, Guidance for Industry, Good Clinical Practice: Consolidated guideline, ICH Topic E6, 1997.

Health Canada, Food and Drug Act– Part C, Division 5, Drugs for clinical trials involving human subjects, August 31 2004. SOP-03

Research Team: Role Definitions, Responsibilities and Task Delegation

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APPENDIX 1

INSTRUCTIONS SPECIFIC TO THE SITE (EXAMPLES)

1. Filing System

2. Location of Filing System

3. Annual Approval or Revision

4. Specific Responsibilities of the Institution

5. Procedures

6. References

7. Appendices

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APPENDIX 2

Date :

TRAINING DOCUMENTATION

Duration :

Training Subject:

Trainer: (block letters)

Title and Department

Trainer’s Signature:

Employee’s Name (block letters)

Page ____ of ______

Signature

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