Investigational Product Management-Study Start Up
The management of an Investigational Product (IP) is a complex and highly regulated activity. The IP may be a drug, biologic, medical device, or combination product; each of which may have unique regulatory and accountability requirements. If the investigator is also serving as the sponsor, additional regulations apply as they are ultimately responsible for accountability of the product.
Being accountable for the IP includes, but is not limited to, documenting the conditions under which the test article was shipped, stored, administered, returned, and/or destroyed, along with any special labeling or quality control measures that may be required. The research team must also be trained on proper administration of the IP as well as any protocol related requirements for its safe and appropriate use such as randomization and un-blinding procedures.
At Penn all investigational drugs should be maintained by the Investigational Drug Services. Please consult with them for more information about storage, handling, labeling, dispensing, randomization and unblinding at: Institute for Translational Medicine and Therapeutics - Investigational Drug Service (IDS).
Research (investigational) medications may refer to any novel therapies (vaccines, biologics, drugs, etc.) or commercially available medications ordered or administered as part of a research protocol.
- All research (investigational) medications for research participants being seen at Penn Medicine locations are to be electronically ordered via PennChart.
- All research (investigational) medications being administered to research participants at Penn Medicine locations are to be documented in PennChart.
- All research studies with research (investigational) medications ordered or administered as part of a research protocol must have a research study “RSH” record in PennChart.
Procedures for requesting research (investigational) medication build in PennChart:
Beacon Protocol Request:
Study team submits Protocol build request form* to PennChart Beacon team using the following link Beacon Protocol Build Request
Pharmacist submits a medication build request form to the Beacon Team using the following link Beacon or Research Medication Build Request.
*The applicable request form (Protocol Build Request or Investigational Medication Build Request) is included in the Athena ticket using the hyperlinks listed above.
Non-Beacon Medication Request:
Pharmacist or Study team submits a medication build request form* to the PennChart Research Team using the following link Beacon or Research Medication Build Request
*The applicable request form (Investigational Medication Build Request) is included in the Athena ticket using the hyperlink above.
Selecting & Qualifying your Investigational Product Vendor:
A clinical trial may include investigational and study products. When selecting and qualifying a manufacturing vendor (or supplier) you should consider the regulatory requirements that apply to the planned trial. The vendor may be a Contract Manufacturing Organization, a Penn Manufacturer, an Industry Partner, or a marketed product that can be purchased through the Pharmacy. The manufacturer is required to comply with good manufacturing practices (GMP), however, depending on the phase of investigation, the GMP standards are different. When working with a device the GMP is outlined in 21 C.F.R. § 820 as well as ISO standards. The following decision tree will help with deciding the standards which should be applied for Drugs based on the phase of your clinical trial:
Decision tree to assist a Sponsor in determining the level of quality required by their manufacturer. This includes tasks recommended for documentation and legal consultation, and provides a workflow for appropriate parties. Copyright: Office of Clinical Research, Penn Medicine
As noted in the decision tree above, when an outside organization is providing investigational product or is performing manufacturing activities, an appropriate agreement should be put into place. Agreements should be finalized prior to any activities related to the clinical trial beginning. The nature and scope of this writing will be determined upon submission to either the Research Information System (RIS) request or PennERA submission. FDA has created a Guidance on agreements for outside manufacturers: or guidance on contract manufacturers. See Contract Manufacturing Arrangements for Drugs: Quality Agreements, for items to consider when entering into an agreement with a Non-Penn manufacturer.
The requirements of the Sponsor are outlined in the table below differentiating Investigational and Study products. Some of the requirements, such as labeling and billing activities can be contracted to the manufacturer or another vendor. Note: please contact the OCR Finance Unit at psom-ocrfin@pobox.upenn.edu for research billing questions. Documentation of manufacturer qualification can be done using the Qualifying Vendor Manufacturing Activities and will be filed in your Trial Master File.
The Sponsor must retain all Essential Documents demonstrating oversight and control of the investigational product in the Trial Master File. Please reference PSOM SOP 003 Investigational Product Management for additional details. If you require assistance with qualification of a device manufacturer or have questions please contact OCR Regulatory at PSOM-IND-IDE@PoBox.upenn.edu
