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.
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 2/2017 LMS link
GA 102 Use and Disclosure of Protected Health Information Preparatory to Research 4/2015
GA 103 UH Research Credentialing 8/2017 LMS Link
GA 104 Scope of Practice 12/2014 LMS Link
GA 105 Investigator Responsibility for Study Team Training and Documentation 10/2017 LMS Link
GA 106 Transfer of Protocols Out of UH In Development
SP 200 Study Planning (SP)
SP 201 Protocol Feasibility Assessment 12/2014 LMS Link
SP 202 Coverage Analysis & Clinical Budget Development Process Flow 6/2017 LMS Link
SS 300 Study Start-Up (SS)
SS 301 Maintenance of Research Regulatory Documents 8/2017
LMS Link
SS 302 UHLSF Outpatient Research Patient Charge Billing Process 12/2014 LMS Link
SS 303 Site Initiation Visit 8/2017 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 6/2017 LMS Link
SC 402 Transportation of Specimens 12/2014 LMS Link
SC 403 Research Documentation 5/2017
SC 404 Transporting Test Article to Other Sites 1/2016
SC 405 Records Retention, Archive and Storage In Development
SC 406 Results Reporting of Clinical Trials in ClinicalTrials.gov 5/2017
SC 407 Reliant Review of CC IRB Approved Cancer Protocols 7/2017
QA 500 Quality Assurance (QA)
QA 501 FDA Inspections of Investigators 11/2017
QA 502 Monitoring Visits 1/2017
QA 503 Corrective and Preventative Action 1/2017

Developed by the Clinical Research Center 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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