Guidelines for Preparing Pharmaceutical Sections

A separate pharmaceutical section is needed for each agent (investigational and/or commercial) used as a part of protocol therapy in a DCTD sponsored clinical trial. The amount of information required is dependent on the type of agent, e.g., investigational vs. commercial agent. Pharmaceutical information for investigational agents should be as comprehensive as possible. For both investigational and commercial agents, extraneous information (e.g., information about tablets when the agent will only be given IV) should NOT be included as it can lead to errors. Pharmaceutical information should be tailored to the specific protocol.

Investigational agents:

Investigators should refer to the appropriate pharmaceutical data sheet and/or Investigator’s Brochure for agent information.

• How Supplied: Include the agent’s NSC #, chemical name, other names, available dosage forms, ingredients and packaging as appropriate. Also state the agent’s supplier, i.e., investigational product supplied by DCTD.
• Preparation (how the dose is to be prepared): Include reconstitution directions and directions for further dilution if appropriate.
• Storage: Include the storage requirements for the original dosage form, reconstituted solution and final diluted product, as applicable.
• Stability: Include the stability of the original dosage form, reconstituted solution and final diluted product, as applicable.
• Route of Administration: Include a description of the method to be used and the rate of administration if applicable. For example, continuous intravenous infusion over 24 hours, short intravenous infusion over 30 to 60 minutes, intravenous bolus, etc. Describe any precautions required for safe administration.
• Other Information: Include any significant potential drug interactions, incompatibilities, special handling, or patient care implications.
• Adverse Events: Adverse event information should be included in the ADVERSE EVENTS: LIST AND REPORTING REQUIREMENTS section of the protocol. For investigational agents the list of adverse events in the protocol must be comprehensive. For CTEP supplied investigational agents, the CAEPR should be used as the comprehensive list and included in its entirety. Note: The Informed Consent document should contain a list of all known adverse events. All adverse events in the informed consent should be written in laymen’s terms.

Commercial Agents:

Investigators should refer to the package insert for agent information.

• Product description: Include any dosage form(s), ingredients, and packaging applicable to the protocol. Also state the agent’s supplier or state that it is commercially available.
• Preparation (how the dose is to be prepared): Investigators may refer the reader to the package insert for ‘standard’ preparation instructions. If the agent is to be prepared by ‘non-standard’ or protocol specific fashion, the reconstitution directions and instructions for further dilution must be included. Appropriate storage and stability information should be included to support the method of preparation.
• Route of administration: Include a description of the method to be used in this protocol and the rate of administration, if applicable. For example, continuous intravenous infusion over 24 hours, short intravenous infusion over 30 to 60 minutes, intravenous bolus, etc. Describe any precautions required for safe administration.
• Refer the reader to the package insert for complete information.
• Adverse Events: Adverse event information should be included in the ADVERSE EVENTS: LIST AND REPORTING REQUIREMENTS section of the protocol. The investigator should list the events most likely to occur in this protocol and refer the reader to the agent’s package insert for the comprehensive list of adverse events. Note: The Informed Consent document should contain a list of all known adverse events. All adverse events in the informed consent should be written in laymen’s terms.

January 2006