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