Questions on blood draw volumes for clinical research

August 12, 2020 Heather Kim

Question:

We are looking at initiating a new blood collection study in late stage cancer patients and are wondering what WCG's guidance is on volume. Is there a maximum volume allowable for this type of patient population? What specific blood collection information needs to be included in the protocol and ICF?

Response:

WCG generally follows the NIH M95-9 “Guidelines for Limits of Blood Drawn for Research Purposes in the Clinical Center”, which has the following recommendations:

  • Adult (18+ years): 10.5 mL/kg or 550 mL, whichever is smaller, over an eight-week period
  • Pediatric: 5 mL/kg in a single day, no more than 9.5 mL/kg over an eight-week period

WCG considers the overall risk of the study, the study population, and the method, frequency, and volume at each blood draw, as well as the total blood collection volume when evaluating a study.

Consistent with the NIH guidelines, in any patient whose clinical condition might be adversely affected by removal of the volumes stated above, for example, patients with significant anemia or compromised cardiac output, investigators should consider further limiting the volume of blood withdrawn for research purposes in excess of clinical need.

The informed consent document should include how often and how much blood will be drawn.  The risks section for the informed consent should also include the potential risks or discomforts from venipuncture such as include temporary discomfort from the needle stick, bruising, bleeding, and rarely may cause infection or fainting.

About the Author

Heather Kim

Heather Kim is the QA Manager at WCG-Copernicus Group IRB. She earned her BS in Biology at the University of North Carolina at Chapel Hill and MS in Regulatory Affairs at Northeastern University. She has worked in Compliance since 2012 and in this role she acts as a regulatory advisor for the IRB, manages noncompliance investigations, manages IRB standard operating procedures, and has hosted numerous clients as well as several FDA inspections with no 483s issued.

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