Prior to IDS involvement, please ensure the following:
- An internal or external IRB review has been completed and there is an IRB approval (IRB #) in place. Ensure that Office of Clinical Trial Activation (OCTA) has been contacted for the start-up of all industry sponsored studies prior to IDS involvement. OCTA provides budgeting services and financial negotiation for industry funded clinical trials. http://trialactivation.ucsf.edu
- The sponsor can direct budgeting questions to the study assigned Budget Analyst in the Office of Sponsored Research (OSR). IDS works closely with OSR and is aligned on current fees.
- Due to pharmacy licensure, IDS can only compound for areas covered under the GACH (General Acute Care Hospital) license, which does not include UCSF campus or ZSFG. We can provide referrals to external pharmacies as needed.
IDS Services:
- Maintain investigational drug accountability:
- Adhere to record keeping requirements
- Maintain investigational drug inventory
- Track dispensed doses
- Subject medication returns
- Maintain temperature control of investigational medications
- Dispense and prepare oral, injectable, hazardous and non-hazardous investigational agents (including blinded doses and/or compounding of placebos)
- Assist with clinical trial budget development for IDS pharmacy fees
- Develop chemotherapy drug order templates
- Develop orders for both hazardous and non-hazardous drugs
- Participate in site qualification, initiation, close-out, other monitoring visits, and site committee meetings
Please note that storage, accountability, preparation, dispensing and security of investigational drugs not handled by IDS pharmacy shall be the direct responsibility of the principal investigator or his/her designee (see Medication Management: Investigational New Drugs policy)