Writing, Approving and Controlling SOPs

1. Purpose

This SOP describes how [SITE NAME] writes, reviews, approves, issues, trains on, revises and retires its standard operating procedures (SOPs), study-specific work instructions and controlled forms. It also sets the order of precedence between site SOPs and the regulatory, IRB, protocol and sponsor requirements that apply to each study, and describes how the site adopts this SOP library from the template.

2. Scope

This SOP applies to all controlled documents in the [SITE NAME] quality system: SOPs, work instructions, controlled forms and logs, and the SOP Master Index. It applies at every location operated by [SITE NAME].

It does not cover study documents written by sponsors or IRBs (protocols, manuals, consent form templates, IRB policies). The site follows those documents as issued and controls them through SOP-204 Essential Documents and the Investigator Site File.

Throughout this SOP library, follow the protocol, sponsor or IRB requirement where it is stricter than the SOP.

3. Responsibilities

4. Definitions

5. Procedure

5.1 Order of precedence

• applicable law and regulation (for example, 21 CFR 50, 54, 56, 312, 812, HIPAA, state law)
• determinations and policies of the reviewing IRB for the study
• the IRB-approved protocol and sponsor written instructions that apply to the study (for example, pharmacy manual, laboratory manual, clinical trial agreement terms)
• [SITE NAME] SOPs
• [SITE NAME] work instructions and job aids

5.2 Document types and numbering

• 100 Governance and quality system
• 200 Start-up and regulatory
• 300 Study conduct
• 400 Data, privacy and systems
• 500 Safety
• 600 Monitoring and closeout
• 700 Quality assurance
• 800 Investigator-initiated research
• 900 Network (Model N only)

5.3 Writing a new SOP or work instruction

• the procedure states who does what, when, and which record proves it
• one process per SOP; cross-reference other SOPs instead of repeating them
• must, should and may are used only with the meanings in Section 4
• regulatory citations are checked against the current text of the regulation or guidance
• site-specific values are shown as placeholders or [DEFAULT: ...] values until decided

5.4 Review and approval

• SOPs: Author, Quality Lead, Site Director, and the PI or Medical Director where 5.4.1 applies
• Work instructions: Author and Quality Lead; add the PI for a study-specific WI that affects participant care or data
• Controlled forms: Quality Lead, with the parent SOP or as a minor change

5.5 Effective date and training before effective

5.6 Issue and access

5.7 Periodic review

• no change needed: the version number stays the same; the review date is recorded and the next review date is set
• minor change: revise under 5.2.4
• major change: revise and approve under 5.3 and 5.4

5.8 Obsolete versions

5.9 Deviations from an SOP

• whether it also is a protocol deviation or a regulatory noncompliance (if so, it is handled under SOP-308 as well)
• whether participant safety, rights or data reliability were affected
• whether the SOP is wrong, unclear or not trained, or whether the staff member did not follow it

5.10 Adopting this SOP library from the template

• replace every bracketed placeholder (for example, [SITE NAME], [CENTRAL IRB NAME], [STATE]) with the site's information
• resolve each "Site decision" box by writing the decision into the box, or replacing the box with the resulting procedure text
• confirm or change each [DEFAULT: ...] value and remove the DEFAULT marker
• complete Appendix A State Law Worksheet for every state where the site has a location or enrolls participants, with sources and the date checked
• read the Regulatory Currency Note and confirm each listed item against current sources
• delete or mark "not applicable" any SOP or section for activities the site does not perform (for example, SOP-800 if the site never holds an IND or IDE), and record that decision on F-100-03
• compare each SOP with current practice, sponsor contract obligations and the reviewing IRB's policies, and list gaps that need resources or training

5.11 SOP control in a network (Model N only)

This section applies only in Model N. Model S sites skip it.

• network SOPs: Author, Network Quality Lead, the Network Executive (SOP-900), and the Network Medical Director or a PI named by the Network Office where 5.4.1 applies
• adoption at each member site: Site Director and Site Quality Lead, recording that the site has adopted the version and trained staff before the effective date (5.11.5)
• local addenda: Author, Site Quality Lead, Site Director, the site PI or clinical approver where 5.4.1 applies, and the Network Quality Lead, who confirms the addendum does not lower a network requirement
• site-only SOPs and site work instructions: as in 5.4.3, with notice to the Network Quality Lead

6. Related Forms and SOPs

• F-100-01 SOP Review and Approval Record
• F-100-02 SOP Training Acknowledgment
• F-100-03 SOP Master Index and Review Schedule
• F-103-01 Staff Training Log
• F-306-01 Note to File
• F-703-01 CAPA Record
• F-702-01 Inspection Request and Document Log
• F-900-01 Local Addendum to a Network SOP (Model N only)
• F-900-02 Network Operating Model and Appendix B Adoption Record (Model N only)
• Appendix A State Law Worksheet
• Appendix B Central and Site Responsibility Matrix (Model N only)
• SOP-103 Staff Qualification, Training and Training Records
• SOP-204 Essential Documents and the Investigator Site File
• SOP-308 Protocol Deviations and Noncompliance
• SOP-401 Computerized Systems and Electronic Records
• SOP-402 Record Retention, Archiving and Destruction
• SOP-703 Corrective and Preventive Action (CAPA)
• SOP-900 Network Governance, SOP Hierarchy and Local Addenda (Model N only)
• SOP-901 Member Site Onboarding, Integration and Exit (Model N only)
• SOP-903 Network Oversight of Member Sites (Metrics, Central QA, Escalation) (Model N only)

7. References