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Site operations template

SOP Starter Kit

Blank, printable outline for a site logistics SOP. Print or Save as PDF from your browser — nothing is uploaded. Customize before using in a regulated binder.

CRA checklistZero-PHI Architecture

Site SOP Starter Kit (Template)

Site ID
________________
Protocol
________________
Date generated
29 Jul 2026
Zero-PHI
Client-side logistics only

Administrative template only. Not legal advice. Do not record subject names, MRNs, DOBs, or other identifiers on this sheet.

1. Purpose

  • Define site procedures for [process name] that support protocol compliance and inspection readiness.
  • This template is a starter outline only — adapt to your IRB, sponsor, and institutional SOPs before use.

2. Scope

  • Applies to: CRC / pharmacy / lab staff at Site ID ____________
  • Does not replace protocol-specific manuals, pharmacy SOPs, or sponsor manuals.
  • Zero-PHI logistics only — do not paste subject identifiers into working drafts of this SOP.

3. Responsibilities

  • PI: oversight and final approval of this SOP and related deviations.
  • CRC / Site Manager: day-to-day execution, training, and version control.
  • Delegated staff: follow current approved version; escalate gaps immediately.

4. Procedure (fill in site steps)

  • Step A: _______________________________________________________________
  • Step B: _______________________________________________________________
  • Step C: _______________________________________________________________
  • Documentation location (binder / eTMF path): ___________________________
  • Escalation contact if process fails: ___________________________________

5. Related records

  • Logs / forms referenced: ______________________________________________
  • Retention per institutional policy: ___________________________________
  • Cross-check with CRA monitoring checklist before monitoring visits.

6. Training & version control

  • Version: ____ Effective date: ______________ Supersedes: ____
  • Training completed (print name / date / initials):
  • 1. _________________________ ____/____/________ ______
  • 2. _________________________ ____/____/________ ______
  • 3. _________________________ ____/____/________ ______

Approved by (PI / Site Manager): _______________________________ Date: ______________

Physical signature (PI / CRC)

 

Signature

 

Printed name / date

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Administrative reference only. Browser-local tools — not a medical device, CDSS, or Part 11 system. Verify outputs against protocol SOPs and primary site records. Zero-PHI local mode: do not enter names, MRNs, DOBs, or subject IDs. Study / kit / lab / deviation / IP accountability / equipment / regulatory / visit drafts use this workstation's localStorage until you clear them. On shared clinic PCs, clear all local site data when finished.