IDS Protocol Submission and Initial Budget Assessment

When setting up your study and considering logistics prior to IRB or grant submissions, provide as many known details as possible to the IDS and send a copy of your protocol and drug preparation manual, if one is available. A clinical research pharmacist will review and assess overall feasibility as well as develop a pharmacy budget assessment which includes medication/supply costs (if applicable) and standard fees for service based on work effort involved to initiate and maintain the trial. Additional costs may be included if IDS will need to purchase commercially available products or additional supplies needed for drug administration.

The research pharmacist will also confirm that IDS involvement is necessary for accountability and handling. The IDS must manage trials involving controlled substances and sterile products as well as all inpatient trials, though CHOP inpatient pharmacy may verify orders and dispense initial doses if needed for inpatient administration at any time outside of IDS hours of operation once the study is initiated by the clinical research pharmacist. Additionally, a clinical research pharmacist is on-call and available 24/7 to provide assistance with randomization and coordinate dispensing activities with inpatient pharmacy. Certain trials may request and receive approval to store investigational products outside of the IDS, depending on logistics and rationale, as long as the supplies are stored and dispensed appropriately.