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Cancer 

Clinical 

Trials 

Centre Standard 

Operating 

Procedure SOP  

No.: 48

Title: Obtaining  

Research  

Blood  

Samples

Current  

Version  

No.: 1.0 Reviewed  

&  

Endorsed  

by  

STH  

Research: 15/02/2018 Approved: 20/02/2018

Effective  

Date: 03/04/2018

SOP  

Version  

History Version 1.0

Approved

Effective  

Date

20/02/2018

03/04/2018

Reviewed No  

Changes

Ended

CCTC  

SOP  

Front  

Cover  

v4.0  

  

06/10/2017

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Cancer Clinical Trials Centre – Standard Operating Procedure Obtaining Research Blood Samples

Objective To describe the procedure for ensuring safe and accurate serial PK and PD blood sampling and any other blood sample collection for research purposes. This SOP applies to all blood samples taken as part of the protocols managed by the Cancer Clinical Trials Centre (CCTC). Definition PK samples Pharmacokinetics is the study of the bodily absorption, metabolism, distribution and excretion of drugs using biological samples. PD samples Pharmacodynamics is the study of the action of a drug in the body over a period of time including the absorption, distribution, localization in the tissues, bio-transformation, and excretion using biological samples. These samples will be specific to each individual protocol and detailed handling instructions will be outlined in each study protocol or study laboratory/sample manual. Please note that PK/PD samples are only taken for research purposes as per a specific controlled and approved protocol and must not be used for pre- or post- treatment assessment of blood values. Responsibilities Any member of staff taking a research related blood sample should have knowledge of the Standard Operating Procedures that cover their working practice. The responsibility for research blood sampling will be delegated by the Principal Investigator for each trial. Details of staff performing this procedure should be recorded on an appropriate log, which forms part of the Investigator Site File. It is the responsibility of the CCTC Research Nursing team to ensure all staff undertaking this procedure has knowledge of this SOP. It is the responsibility of the practitioner to be competent in the clinical skills required to adhere to this SOP. It is the responsibility of the CCTC Research Nurse managing the study to ensure that all trial related instructions relating to sample timings and processing are overseen with instruction given to the staff obtaining the samples. Any required study specific training should be read, understood and completed prior to carrying out any study related procedure. Procedure A calibrated digital clock should be used to record the exact time that a PK/PD sample is taken and the start and stop time of a treatment infusion. The same digital clock will be used to record the times of when all the samples are taken for a patient. Samples should be taken according to the timings on the schedule provided on the research proformas and/or laboratory/sample manual. The date and time of all samples obtained should be recorded on the research proforma and/or in the patient medical records. SOP 48 – Obtaining Research Blood Samples v1.0 Finalised: 13.02.2018 Page 1 of 4

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All samples should be processed according to the specific study laboratory/sample manual immediately after obtaining. PK/PD samples CANNOT be taken from a portacath or Hickman line device, as they require a heparin flush which would denature any PK/PD sample. Intravenous access & pre-treatment PK/PD sample: 1. For patients requiring multiple blood sampling on day 1 of treatment, two separate intravenous (IV) access devices (e.g. cannula) should be available in opposite arms to ensure that the PK/PD blood sample is taken from a different arm that is having the IV infusion treatment. The IV access will be referred to as, e.g. a. Treatment cannula b. Sample cannula 2. A pre-treatment sample may be taken from the treatment cannula prior to starting treatment but once treatment has been commenced all further samples must be taken from the sample cannula. 3. Siting of the IV cannula should be done by a competent practitioner and according to the appropriate Sheffield Teaching Hospital NHS Foundation Trust (STH) guideline. 4. Full assessment must be taken to consider the cannulation site and size of cannula to be used. Consideration should be given to using a large gauge cannula in the forearm where possible. 5. PK sampling may not be achievable for patients who do not consent to have both arms cannulated, e.g. breast cancer patients that have potential concerns over developing lymphoedema in arms affected by lymph node surgery. Alternative areas of venous access in other limbs is not advised unless in emergency care situations, according to STH guidance. Further Day 1 PK/PD samples: 1. Immediately prior to taking the PK/ PD sample take 2mls of blood from the sample cannula and discard. 2. Take another sample from the cannula and note the exact time of the sample. This time should match the scheduled proforma for sample collection for the specific study. 3. The specific sample collection bottles as stated in the protocol should be used. If none are specified then STH sample collection bottles may be used. Ensure that the samples are identifiable to the patient and that any specific labeling is done according to the protocol and study laboratory manual requirements. 4. After the sample has been taken with a syringe, the sample cannula should be flushed with 1-2 mls of 0.9% sodium chloride solution as per STH policy and replaced with a new binnector after every sample. 5. If the cannula loses its patency after multiple draws from a syringe then consideration should be given to a slow infusion of 10mls/hr to improve venous access. 6. Patients receiving day case treatment will have the IV sample and IV treatment cannula removed before being discharged. 7. Post dose sampling after Day 1 following drug interruption may occur up to 96 hours or more post treatment. Therefore the sample will have to be taken via other routes.

SOP 48 – Obtaining Research Blood Samples v1.0 Finalised: 13.02.2018 Page 2 of 4

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Double lumen / single lumen PICC lines PK/PD samples can be taken from a double lumen PICC / single lumen PICC devices from a competently trained practitioner following the same process outlined as above. Blood samples taken from a PICC line post day 1 infusion should be taken according to the appropriate STH guideline. Peripheral collection via venepuncture: Venepuncture should be carried out according to the appropriate STH guideline. Samples should be collected from the opposite arm of the infusion. There are no restrictions with oral medications. Safety The STH Infection Control guidelines and policies should be followed at all times. Where applicable, the relevant STH guidelines for handling cytotoxic drugs should be followed at all times. Waste should be disposed of as per relevant STH waste disposal guidelines.

References & Related Guidelines Sheffield Teaching Hospitals Guidelines and Policies, including Drug Administration and Anti-Cancer Drug Guidelines can be accessed on the Sheffield Teaching Hospitals intranet at http://nww.sth.nhs.uk/NHS/ClinicalGuidelines

SOP 48 – Obtaining Research Blood Samples v1.0 Finalised: 13.02.2018 Page 3 of 4

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SOP Revisions & History SOP Version No.

Effective Date

1.0

Reason for Change / Review and Summary of Main Changes This Version First version of a new SOP Previous Versions

Authors/ Reviewers AC, RE

SOP Approval Date of STH Research endorsement

15/02/2018

Endorsed by (STH Research name & signature )

Dr Dipak Patel, STH Research Manager

Date of approval by CCTC Director / CCTC Management Team

20/02/2018

Approved by (CCTC name & signature)

Dr John Wadsley, CCTC Director

Next review date

March 2020

SOP 48 – Obtaining Research Blood Samples v1.0 Finalised: 13.02.2018 Page 4 of 4

Professional Memo

Feb 15, 2018 - AC, RE. Previous Versions. SOP Approval. Date of STH Research endorsement. 15/02/2018. Endorsed by (STH Research name & signature ). Dr Dipak Patel, STH Research Manager. Date of approval by CCTC Director /. CCTC Management Team. 20/02/2018. Approved by (CCTC name & signature).

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