Standard Operating Procedures - General Training

Standard Operating Procedures
(SOP)
General Training

Standard Operating Procedures
General training
• SOPs are « detailed, written instructions to achieve uniformity of
the performance of a specific function. » (ICH)
• SOPs apply to all research projects or clinical trials (sponsored or
contractual) with human subject

Objectives of Standard Operating Procedures
• Subjects are protected through standardized and well established
work practices
• Compiled & published data are compliant with applicable
regulations
HOW ?
By realizing all clinical trials in accordance with the good clinical
practice (GCP) and to the applicable regulatory requirements

Development of SOP
• Phase I
– Professionals from the Health Care Institutions
– An observer from Health Canada
– Professional consultants
• Phase II
– Site personnel
– Support from a team of professional consultants

Structure of Standard Operating Procedures
• Policy
• Objective(s)
• Site Responsibilities
• Procedures
• References
• Appendices

Content of Site Standard Operating Procedures
• SOPs are adapted and personalized
– According to each site’s profile
– In relation with the « cadre réglementaire » and other
applicable documents of the site

References used for Standard Operating Procedures
• International conference on harmonisation (ICH)
• Declaration of Helsinki
• Tricouncil Policy Statement ; Ethics for Research Involving
Human Subjects
• FRSQ
• Act and regulation of Quebec
• MSSS
• Health Canada
• The « cadre réglementaire » and other regulatory documents of
the site
• SCDM – Society for Clinical Data Management (US)
• FDA

To whom Standard Operating Procedures are for ?
SOPs applies to all clinical research personnel involved in the
research center

Standard Operating Procedures
SOP
Preparation
CTA
SOP01 Development, Approval
and review of Standard
Operating Procedures (SOPs)
SOP02 Organizing a site for
Clinical Research
SOP03 Research team: Role
Definitions, Responsibilities and
Task Delegation
SOP04 Site Research Team :
Competence, Knowledge and
Training
SOP05 Preparing the Team for a
Study
SOP06 Study Feasibility
Assessment
•SOP07 Conducting a Study in
the Context of a Clinical Trial
Application in Canada (CTA)

Standard Operating Procedures
Ethics Committee
Subjects
Conflict et Misconduct
SOP08 Protocol and Protocol
Amendment, Submission to
Research Ethics Board
SOP09 Consent Process and
Subject Informed Consent Form
SOP10 Rights and Protection of
Study Subjects
SOP12 Subject Recruitment
SOP13 Subject Follow-up
SOP11 Conflict of Interest
SOP14 Dealing with Misconduct
And Protocol Deviations
SOP15 Research Ethics Board
(REB): Ongoing
communications

Standard Operating Procedures
Management and data
SOP16 Management of Communication During a
Study
SOP17 Management of Adverse Events – Serious
Adverse Events and Adverse Reactions – Serious
Adverse Reactions
SOP18 Managing of Investigational Products Under
Study
SOP19 Management of Biological Specimens:
Collection and Storage
SOP23 Management of Data and Source Documents
SOP24 Clinical Data Management, Paper or
Electronic Format
SOP25 How to fill In a Case Report Form and Modify
Data
SOP26 Security and confidentiality of Data
SOP20 Preparation for
Monitoring Visits
SOP21 Preparation for an
Audit or Inspection
SOP22 Study Closure

Complement to Standard Operating Procedures
• Terminology and acronyms
– An Acronyms and terminology list is available to facilitate the
SOP reading

Accessibility to the Standard Operating Procedures
• Through the Institutional Intranet network
• Through the research center secretariat

Questions ?
Standard Operating Procedures
General training