Clinical Study SOPs

The ICH GCP (International Conference on Harmonisation of Good Clinical Practice) states that “systems with procedures that assure the quality of every aspect of the trial should be implemented”. Our SOPs listed below for Clinical research detail the procedures
that we follow to insure GCP.

  1. Obtaining Informed Consent

    This SOP was developed to ensure that the process for gaining informed consent is standardised throughout all studies adopted by the SDRN and adheres to ICH GCP (1997) guidelines.

  2. Urinalysis

    To describe the procedures for urinalysis and to promote uniformity within the SDRN sites in accordance with ICH GCP guidelines.

  3. 24 Hour Urine Collection

    To describe the procedure for collecting a 24 Hr urine sample and promote uniformity within the SDRN in accordance with ICH GCP guidelines.

  4. Venepuncture & Blood Sampling

    To describe the procedure for taking blood samples for biochemical and genetic analysis and to promote uniformity within the SDRN in accordance with ICH GCP guidelines.

  5. Measurement & Recording of Height

    To describe the procedure for the measurement and recording of height and to promote uniformity within the SDRN in accordance with ICH GCP guidelines.

  6. Measurement of Weight & Bioimpendance & BMI

    To describe the procedure for the measurement of weight and bioimpedance and calculation of BMI and to promote uniformity within the SDRN in accordance with ICH GCP guidelines.

  7. Waist-Hip Ratio

    To describe the procedure for the measurement of waist and hips and to promote uniformity within the SDRN in accordance with ICH GCP guidelines.

  8. Physical Measures – Blood Pressure & Resting Pulse

    To describe the procedure for obtaining BP and pulse recordings and promote uniformity throughout the SDRN, in accordance with ICH GCP guidelines.

  9. Electrocardiograph Recording

    To describe the procedure for obtaining an electrocardiograph on patients and promote uniformity within the SDRN in accordance with ICH GCP guidelines.

  10. Ankle – Brachial Pressure Index

    To describe the procedure used within the Scottish Diabetes Research Network for measuring the ankle brachial pressure index of each subject.

  11. Completing the Permission to Contact Form

    Giving all people with diabetes the chance to participate in research projects means populating a database, the ‘Research Register’, of those who would be interested in learning more about research projects with a view to participating in them.

  12. Withdrawal from the Research Register

    All patients who join the Research Register must be fully informed of the Withdrawal Procedure for temporarily or permanently withdrawing themselves from the Research Register.

  13. Research Nurse Training

    To describe the procedures used within the Scottish Diabetes Research Network to ensure that all nurses working on SDRN studies are competent to perform this research to the highest possible standard and to ensure the integrity of the data.

    (Appendix A) Learning Plan
    (Appendix B) Training Record

  14. Completing the Case Report Form

    To describe the procedure used within the Scottish Diabetes Research Network for completing Case Report Forms (CRF)

  15. Adverse Event Reporting

    This SOP was developed to ensure that the process used to document and report adverse events is standardised throughout all studies adopted by SDRN.

    (Appendix A) Adverse Event Form

  16. Site Selection Visits

    The site selection visit by a Sponsor is a crucial meeting as first impressions of the Research Unit can affect the future relationship between site staff and Sponsoring Companies/Charities.

  17. Serious Adverse Event Reporting

    This SOP was developed to ensure that the process used to document and report Serious Adverse Events and SUSARS is standardised throughout all studies adopted by SDRN.

    (Appendix A) Serious Adverse Event Form

  18. Completing the Minimum Dataset Form

    The SDRN Portfolio holds information relating to individual studies taking place in Scotland and is used to give an overall picture of Diabetes Research in Scotland. The Minimum Dataset Form must be fully completed before studies can be entered into the portfolio.This SOP is to provide clear guidance on the information needed in order to complete each field of the Minimum Dataset Form.

    (Appendix A) Minimum Dataset Form

  19. Clinical Study Risk Assessment

    To describe the procedure for the assessment of risk within clinical studies conducted within (as defined by the study being adopted by the SDRN) the Scottish Diabetes Research Network. The use of the forms provided will also ensure that risk assessment is carried out uniformly across SDRN sites in accordance with ICH-GCP guidelines.

    (Appendix A) Clinical Study Risk Assessment
    (Appendix B) Delegation of Responsibilities Log
    (Appendix C) Delegation of Responsibilities Log Delegated Tasks

  20. Insertion & Removal of a Peripheral Intravenous Cannula

    Peripheral intravenous infusion is a procedure whereby a device, such as a cannula with a flexible tube containing a needle, is inserted into a small peripheral vein for the purpose of administering fluids and/or medications or the obtaining of blood samples.

  21. Collection of Blood Samples from a Peripheral Venous Cannula (PVC)

    Peripheral venous cannulation is performed to provide access to the circulatory system. Research studies may require multiple blood sampling. Blood may be drawn from a peripheral venous cannula at frequent time points and to avoid repeated venepuncture. For the purpose of clinical research a peripheral venous cannula may be in situ for a few minutes or hours.

  22. Administration of Medications and Fluids via a Peripheral Intravenous

    Peripheral intravenous infusion is a procedure whereby a device is placed into a patient’s vein. A cannula is a flexible tube containing a needle that may be inserted into a blood vessel. The needle is removed once the cannula is in position. This then enables venous access for the administration of medications and fluids via this route. The intravenous route is one of the fastest ways to deliver fluids or medications.

  23. Blood Glucose Monitoring

    Blood Glucose is performed to provide an indication on how the body is controlling glucose metabolism. When performing blood glucose monitoring staff should be trained in both the theoretical and practical aspects including the use of the device and instruction on calibration of quality control.

  24. Implementing the Research Register in General Practice

    The purpose of this SOP is to describe the process that SDRN staff should follow when contacting GP practices in order to expand the geographical distribution of the Research Register and to encourage collaboration with the Primary Care Community. By following the directions in this standard operating procedure it is expected that practices will be assured that the letters being sent to their patients will not be a source of anxiety or unease to the practice or patients.

  25. Entering Patients into the SDRN/SCI-DC Research Register

    To describe the steps that should to be followed by the individual entering data onto the Permission to Contact data entry pages on SCI-DC and how to process the Research Register documentation.

    (Appendix A) SDRN/SCI-DC Research Register Data Entry – User Guide

  26. SDRN & Personal Identifiable Data (PID) in Clinical Use

    To describe the steps that should to be followed by the individual regarding PID. We can never overstate the importance of understanding what it is and how we are all responsible for keeping information secure.

  27. Management of Hypoglycaemia

    The aim of this SOP is to describe the symptoms of hypoglycaemia and the action required to correct this condition in order to ensure the safety of patients involved in clinical research studies.

  28. Management of Exposure to Needlestick & Body Fluids

    The purpose of this policy is to ensure that all health care workers who experience a needlestick injury, or have a mucocutaneous exposure to blood or body fluids, are aware of the correct action to take to deal with the situation rapidly and appropriately.

  29. Requesting a Search of the SDRN RR

    To describe the process of how NHS and University research staff request a search of the SDRN Research Register Database.

  30. Completing the SDRN Study Tracker

    The tracker should function as a point of reference for site staff to help them in the planning of their workload when determining what studies to undertake at any given time.

  31. Monitoring and Recording Refrigerator & Freezer Temperatures

  32. Use of the Centrifuge

  33. Collection of a Urine Sample for Research Studies

  34. Transportation of Samples

  35. Handling Dry Ice

  36. Monitoring a Clinical Trial Operating an Electronic Case Report Form (eCRF)

  37. Voluntary Withdrawal of Consent from a Clinical Trial(Voluntary Withdrawal of Consent Form)

  38. Management of Clinically Significant Blood Pressure Measurements in a Clinical Trail