Research Standard Operating Procedures

What are Standard Operating Procedures (SOP)?

“Detailed, written instructions to achieve uniformity of the performance of a specific function.” (ICH GCP 1.55)

In simple terms an SOP is a written process and a way for the clinical site to perform a task the same way each time it is completed.

SOPs are used to:

  • Identify the responsible person for each task;
  • Describe what is to be completed;
  • Train staff; and
  • Monitor site performance.

What are the benefits of using SOPs?

  • SOPs ensure that sites follow Federal Regulations, International Conference on Harmonization Good Clinical Practice Guidelines, and UH Institutional Policies to protect the rights and welfare of human study participants.
  • They improve quality of data collected and improves research,
  • Provide a reference and guideline for conducting research, and
  • Act as a training tool for new employees and/or trainees.
Research SOP Table of Contents
SOP Number Title Version LMS Training
Glossary of Terms for Standard Operating Procedures
GA 100 General Administration GA
GA 101 Development and Maintenance of Standard Operating Procedures 12/2014 LMS link
GA 102 Use and Disclosure of Protected Health Information Preparatory to Research 4/2015
GA 103 UH Research Credentialing 12/2014 LMS Link
GA 104 Scope of Practice 12/2014 LMS Link
GA 105 Investigator Responsibility for Study Team Training and Documentation 12/2014 LMS Link
GA 106 Transfer of Protocols Into and Out of UH In Development
SP 200 Study Planning (SP)
SP 201 Protocol Feasibility Assessment 12/2014 LMS Link
SP 202 Coverage Analysis & Clincal Budget Development Process Flow 12/2014 LMS Link
SP 203 Coordinating Multiple Sites and Satellite Site Management 3/2015
SS 300 Study Start-Up (SS)
SS 301 Maintenance of Research Regulatory Documents 12/2014 LMS Link
SS 302 UHLSF Outpatient Research Patient Charge Billing Process 12/2014 LMS Link
SS 303 Site Initiation Visit 10/2014 LMS Link
SS 304 Investigational Drug Billing 12/2014 LMS Link
SS 305 Investigational Device Billing 11/2014 LMS Link
SS 306 Investigational Pharmacy Fee Waiver 7/2015
SC 400 Study Conduct (SC)
SC 401 Registration of Clinical Trials in ClinicalTrials.gov 10/2014 LMS Link
SC 402 Transportation of Specimens 12/2014 LMS Link
SC 403 Research Documentation In Development
SC 404 Transporting Test Article to Other Sites In Development
SC 405 Records Retention, Archive and Storage In Development
QA 500 Quality Assurance (QA)
QA 501 FDA Inspections of Investigators 10/2014 LMS Link
QA 502 Monitoring Visits In Development
QA 503 Corrective and Preventative Action In Development

Developed by the Center for Clinical Research and Technology Clinical Research SOP Committee

Tips for writing SOPs

  • Determine a single task to focus on.
  • List all the steps currently used to complete that task.
  • Take each step in the task and make it more efficient and easier to follow.
  • Following the template, fill in each step.
  • Use clear, concise language.
  • Use the active voice when writing.
  • Avoid names; use job functions instead.

Things to Remember

  • The Principal Investigator should approve all SOPs and designate an effective date.
  • SOPs should be reviewed on a regular basis (usually annually) to ensure policy based regulations are up-to-date.
  • Previous versions of SOPs should be retained.
  • All staff should have SOP training (document this training)
  • SOPs should be accessible to staff
  • SOPs are an integral part of good research practice!

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