Subcutaneous Injection Technique

Subcutaneous Injection Technique Page 1 of 3 1. PURPOSE This Standard Operating Procedure (SOP) provides instructions on administering Investigational Medicinal Product (IMP) subcutaneously and the process to ensure study participants required to self-inject are trained, according to the requirements of the study protocol, in the storage, method of administration and record keeping for IMP given by Subcutaneous Injection. 2. SCOPE This SOP applies to all studies where study participants are required to subcutaneously inject IMP. This SOP should be used by all members of the clinical research team who are delegated the responsibility of ensuring patient can safely administer the IMP. 3. PROCEDURE 3.1 Injection Preparation and Technique 3.1.1 3.1.2 3.1.3 3.1.4 3.1.5 3.1.6 3.1.7 3.1.8 3.1.9 3.1.10 3.1.11 Gather all necessary supplies for giving the injection including prefilled syringe and sharps container on a well-lit, clean surface. Dispose of the syringe if the expiry date has passed, the medicine is cloudy, discoloured, has particles or is damaged. If the syringe has been refrigerated, wait for 25-30 minutes for the syringe to come to room temperature. Wash hands with soap and water. Choose injection site, usually abdomen, upper outer aspect of the thigh or the upper outer aspect of the arm. Remove cap from needle by firmly gripping the syringe with one hand, try not to press the plunger, and pull the cap straight off with the other hand. The syringe should be used immediately. Once the cap has been removed from the needle it should not be replaced. Pinch the skin at the injection site; insert the needle with a quick, firm action. The needle may be inserted between 45 and 900, insert the needle all the way in, keep the syringe in position and let go of the pinched skin. Slowly inject the medicine by gently pushing the plunger all the way down. When the plunger is all the way down, keep pressing down to be sure the medication has been injected. In most cases, and unless otherwise specified, keep the plunger pushed down while you take the needle out of the skin at the same angle it was inserted. Release the plunger and dispose of the syringe as per study protocol or instruction from pharmacy. Needles must always be disposed of in a sharps container but empty packaging may be required to be returned to pharmacy, check individual protocol requirements 3.2 Participant Training 3.2.1 Training for trials of Investigational Medicinal Products (IMP) that require to be administered by Subcutaneous Injection must be performed at the start of the trial when study personnel will need to demonstrate and advise the patient on study drug administration technique. Participants should be advised of the following:  Storage requirements for IMP - Most SC medication will require to be stored in a refrigerator, at a temperature of 2-80C, kept dry and protected from freezing and light. Check study protocol for specific requirements.  Usage and Disposal - SC medication is for single use only and should then be discarded in the appropriate supplied sharps container. 3.2.2 Page 2 of 3    Frequency - Injections may need to be given every week or every other week or as directed by study protocol. Record-keeping – Participants will be required to keep a record of all study medication self-administered usually in the form of a diary card and may be required to return empty packaging to the study site at each study visit to confirm compliance. Check individual study protocol requirements. Follow-up – Participants must have regular checks to reaffirm their understanding of the administration technique and to assess their compliance with the protocol. This must be documented to demonstrate it has been undertaken. Page 3 of 3