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SOPs

The Scottish Children’s Research Network (ScotCRN) and Tayside Children’s Clinical Research Facility have developed Standard Operating Procedures (SOP) and guidelines for use in Clinical Trials of Investigative Medicinal Products (CTIMPs) and Non-CTiMPS.

The SOP’s and guidelines relate to research governance and study interventions specific to the paediatric population and have been nationally approved. 

These SOP’s can be used in conjunction with the University of Dundee and NHS Tayside accredited (SOPs) to provide guidance for the safe and appropriate involvement of children in research studies.

During the CTIMP Sponsorship Approval Process the SOPs to be used during the course of the study will be agreed and documented in a (study-specific) SOP log.

At the Monitoring visit, and any other GCP Monitoring visits, the Clinical Trial Monitor will validate that you are utilising the appropriate SOPs and versions. Any changes to SOPs used during the course of the Study should be documented in the SOP log.

SOP’s can be obtained on request, please see contacts 

Quality and Safety

  • Use of Electrical Equipment (SOP 18)

  • Monitoring and Recording of Refrigerators and Freezer Temperatures (SOP 24)

Research Governance

  • The Guidance on the Preparation, Maintenance, Approval and Review of Standard Operating Procedures (SOP 20)

  • Reporting Adverse Events (SOP 9)

  • Data Protection (SOP 26)

Safety and Pharmacovigilence

  • Storage of Medicines in CRF’s (SOP 19)

Trial Management

  • Obtaining Informed Consent & Assent for Research Studies (SOP 1)

  • Withdrawal of Informed Consent & Assent (SOP 2)

  • Measurement and recording of height (SOP 3)

  • Measurement and recording of weight (SOP 4)

  • Obtaining a Urine Sample (SOP 5)

  • Obtaining a Peripheral Blood Sample (SOP 6)

  • Obtaining a Blood Sample (capillary) (SOP 7)

  • Obtaining and recording a peripheral Blood Pressure and Pulse (SOP 8)

  • Measurement of Exhaled Nitric Oxide (SOP 10)

  • Measurement of Spirometry (SOP 11)

  • Skin Prick Testing (SOP 12)

  • Measurement of Pain (SOP 13)

  • Pregnancy testing in Females aged 12-16 years (SOP 14)

  • Obtaining a Capillary Blood Glucose (SOP 15)

  • Saliva Collection for ECP Levels (SOP 17)

  • Taking a Child’s Body Temperature using a TempaDOT ™ (SOP 21)

  • Assessment of Atopic Dermatitis in children using SCORAD (SOP 23)

  • Saliva Collection for Deoxyribonucleic Acid (DNA) (SOP 25)