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Pediatric Clinical Research Office
Standard Operating Guidelines
Standard Operating Guidelines provide guidance and templates for many common research tasks. Investigative staff use the following processes and procedures to gain quality performance, compliance and to ensure good clinical practice guidelines are followed.
These links are only available to users within the University of Rochester, Department of Pediatrics.
- Guidelines for External Audit/Inspection (SOG0100)
- Study Communications (SOG0101)
- Five-Year Study Renewal Process (SOG0103)
- Research Agreement Review (SOG0200)
- Informed Consent (SOG0201)
- Scientific Review of Clinical Research Projects (SOG0202)
- Protocol Development (SOG0203)
- Informed Consent (Content, organization) (SOG0204)
- Good Clinical Practice (GCP) Guidelines (SOG 0300)
- Subject Recruitment/Payment (SOG0301)
- HIPAA Privacy Compliance for Clinical Research (SOG0400)
- Adverse Event Reporting (SOG0401)
- PI Failure to Submit Yearly IRB Progress Report (SOG0402)
- PCRO Communication of Reportable Events from the Clinical Quality Assurance Review (SOG0403)
- Study Conduct (SOG0404)
- Protocoal Amendments (SOG0500)
- Case Report Forms (SOG0501)
- Document Style Guide (SOG0502)
- Data Safety and Monitoring Guidelines (SOG0605)
- Research Clinical Billing Reviews (SOG0606)
- Complaint Guidelines (SOG0701)
- Study Closure (SOG0702)
- Shipment of Biological Samples/Materials (SOG0800)
- Study Binder Development (SOG0802)
- Clinical Trials.GOV Registration Procedures (SOG0900)
Standard operating guidelines are developed on an ongoing basis and as need dictates. Although the guidelines are developed carefully and reviewed frequently, individual research programs may need to adapt them to their specific needs and regulatory environment.
PCRO