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Guidelines for Writing Standard Operating Procedures (SOP) Page 1 of 8 Written Standard Operating Procedures provide workers with the operational information necessary to perform a job properly and ensure consistency in the operations. Standard Operating Procedures provide a historical record of steps in the how, why and when and serve as a training tool for teaching users. How to write your research site’s Standard Operating Procedures: • Begin by identifying a purpose or a mission statement. Identifying the purpose of your SOP’s will help to focus your energy and set limitations on the necessary content. • Create an outline of what is actually done on a day to day basis. The individual(s) actually performing the task on a regular basis may be the person(s) best qualified to write that SOP. • After an outline of the SOP content has been developed, the structure of the SOPs must be developed. It is important to design your SOPs to achieve specific results. Possible design options: Simple steps Hierarchical steps Graphic procedures SOPs require establishment of procedure codes and topics. It is important to use words such as “will” or “shall” to describe procedural steps. It is best to avoid words such as “should,” “could,” and “may.” These words convey a since of option. SOPs are not optional. • A first draft should then be written and distributed for internal review. Any necessary modifications to procedures can be at this time. This will aid in creating a since of ownership of the document and encourage workers to follow the procedures. • The final version of the SOPs should then be distributed for external review and tested in practice. • The SOPs must then be signed for approval and posted. All employees should be trained on the SOPs. This training should be documented. • The SOPs will be reviewed annually or as needed. Amended SOPs will be distributed to the users and old versions will be destroyed. Archival copies of the SOPs should be maintained by the principal investigator or office manager. Copies of current SOPs should be available in all areas and at each work site where procedures are to be performed. Guidelines for Writing Standard Operating Procedures (SOP) Page 2 of 8 The following is an example of the content necessary for a clinical research site’s SOPs. 1.0-GE General SOPs 2.0-SS Study Start-Up (Site Qualification through Initiation) 3.0-PM Project management (Initiation through Termination) 4.0-SM Subject Management (Screening through Completion) 5.0-DM Data Management 6.0-QA Quality Assurance (Sponsor, Institutional, Site, FDA, etc.) Purpose: To provide guidelines for preparing Standard Operating Procedures (SOPs). GE: General 1.1 GE- Development and Implementation of SOPs How you developed your SOPs. Include: SOP sequence coding, format, sign off, dissemination 1.2 GE- SOP Revision 1.3 GE- SOP Training and Orientation (staff training) 1.4 GE- Statement of General Principles Include: statement of authority, mission statement for the protection of human subjects, declaration that cGCP is followed. 1.5 GE- Responsibilities of Principal Investigator 1.6 GE- Responsibility of Research Team (with an organizational chart) Subinvestigator Project administrator Research coordinator Data manager Pharmacist Laboratory Director SS: Study Start-Up 2.1 SS- Project Feasibility Protocol/Investigator Brochure distribution and assessment Dissemination to study staff for comment Guidelines for Writing Standard Operating Procedures (SOP) Page 3 of 8 Protocol/IB comment tracking Final sign off, comments to sponsor Determine personnel Identify primary contact Project time-line review Meeting: list and clarify ability to carry out trial File report: Decision to Go/No Go 2.2 SS- Communicating with Sponsor/CRO Responsibilities Communication between site/CRO/sponsor Contacts/reporting 2.3 SS- Site Qualification Visits Project team identification Visit preparation Schedule and coordinate Prepare regulatory documents Patient accrual/Project timeline review Carrying out visit Follow-up activities 2.4 SS- Institutional Review Board Regulations Site specific procedures for review Organization/Membership Required documents/forms Advertisements Approval tracking 2.5 SS- Informed Consent Development FDA regulations Institutional Requirements Format and Content Drafting and editing consent document Final approval/sign-off Consent Process Guidelines 2.6 SS- Site Initiation Meeting Pre-meeting preparation Ancillary services training and participation Regulatory documentation collection Patient screening/accrual/tracking Carrying out meeting Guidelines for Writing Standard Operating Procedures (SOP) Page 4 of 8 Post visit responsibilities 2.7 SS- Attending an Investigator Meeting Identifying attendees Staff responsibilities Post meeting 2.8 SS- Project Budgets and Contracts Institution procedures Sponsor requirements Letter of agreement Indemnification Overhead Budget preparation Payment schedule/tracking Definition of subject completion (evaluable subjects) PM: Project Management 3.1 PM- Research Site: Project Start-up Research team responsibilities-training Project expectations Identify primary contact Staff coverage Communication procedures e-mail, fax, phone, correspondence Prepare study files Protocol review/adherence and compliance Study manual review CRF review Subject tracking and compliance Project timeline and test schedule review Sponsor monitoring plan 3.2 PM- Communications IRB/sponsor/CRO/FDA/subject/providers 3.3 PM- Regulatory Files Content of files Organization Periodic Review Accessibility/security Maintenance 3.4 PM- Hospital/Central lab Procedures Guidelines for Writing Standard Operating Procedures (SOP) Page 5 of 8 Lab staff/project team responsibilities/communication Expectations of standards OSHA standards Supply inventory Lab Certification and normals Equipment calibration/maintenance Emergency procedures Reporting 3.5 PM- Drug Accountability/Tracking/Storage Staff responsibilities Ordering procedure Tracking Dissemination/processing Storage/special equipment (temperature logs, etc.) DEA controlled substances Shipping to satellite site/sponsor Return/destruction 3.6 PM- Study Termination Prepare for visit Investigator obligations Visit responsibilities Final form audit/completion Final drug accountability Final document storage: FDA regulations Study summary for IRB, sponsor Follow-up activities Define plan for method of document retrieval SM: Subject Management 4.1 SM- Subject Screening Telephone screening Screening log/charts 4.2 SM- Subject Recruiting Recruitment plan PI/Sub-investigator/Ancillary staff training Monitor enrollment goals, modify and update as needed Accrual reporting 4.3 SM- Informed Consent Implementation Obtaining consent Proxy consent Guidelines for Writing Standard Operating Procedures (SOP) Page 6 of 8 Assent of children Minority recruitment Copy to subject Amendments/tracking 4.4 SM- Randomization/Coding/Blinding/Emergency Unblinding 4.5 SM- Enrollment Procedures Protocol exemptions Remuneration procedures 4.6 SM- Clinical Assessments Scheduled visits Interim visits End-point determination 4.7 SM- Specimen Collection Phlebotomy procedures Processing samples Storage and shipping 4.8 SM- Dose Modification 4.9 SM- Termination Procedures Routine Early Withdraw Subject Initiated Physician Initiated 4.10 SM- Safety Reporting FDA regulations Staff responsibilities Telephone reporting Staff responsibilities AE event determination Written reporting procedures/format: IRB, sponsor Source documentation, tracking and follow-up Dissemination of report for review/final sign off: PI DM: Data Management 5.1 DM- CRF Completion Review for consistency/completion CRF amendments, tracking and sign off Use of sponsor guidelines/coding Guidelines for Writing Standard Operating Procedures (SOP) Page 7 of 8 Investigational site procedures On-site completion of forms Data corrections Remote data forms/ completion/transmission to sponsor 5.2 DM- Source Documentation Medical Records Study Files Laboratory Reports Diagnostic procedure/test Consultation notes Medical/nursing notes 5.3 DM- Database design and management 5.4 DM- Archiving Data Study documentation: CRF, protocol, drug accountability records, correspondence and regulatory documentation file Tracking and updates Procedure to retrieve data QA: Quality Assurance (Sponsor, Investigational Site, FDA) 6.1 QA- On-Going Monitoring Visits Pre-meeting preparation Regulatory documentation review and update Ongoing record keeping Meeting responsibilities/availability of staff Protocol violation Monitor study team compliance Reporting to sponsor Follow-up activities 6.2 QA- Internal Audit Procedures Preparation for audit Conducting the audit Follow-up/closure Final reporting 6.3 QA- Sponsor/CRO Audit Procedures Preparation for audit Audit Visit Guidelines for Writing Standard Operating Procedures (SOP) Page 8 of 8 Follow-up/closure Final reporting 6.4 QA- FDA Inspections Regulations defines Preparation Communication to Sponsor/CRO Conducting the visit Follow-up, closure Final reporting Date Prepared: 09 February 2004 Effective Date: 12 February 2004 Supersedes Dates: Prepared By: Samanthia Beavers Approved By: Juliann Tenney, JD Associate Dean for Compliance
