Getting Started with Investigational New Drug (IND) / Investigational Device Exemption (IDE) Applications

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If you are a CHOP researcher who may need to apply for an Investigational Drug Application (IND) or Investigational Device Exemption (IDE) for use of a drug or device in your research, the Investigational New Drug and Device Support Program (IND/IDE) provides sponsor support services and connects sponsors to resources for successful trial execution. The IND/IDE Support Office will assist with FDA submissions, study design questions, and will provide training to study teams. Learn more about clinical research at CHOP by visiting the "How to Start a Clinical Research Study" resource page.

The IND/IDE Support Office can offer assistance with the following: Provide training and consultation for protocol development/review and navigating and operationalizing study start-up, management, and closure at CHOP.

Development

Protocol Development

The key to creating a well-designed clinical research study begins with the creation of a well-developed protocol. The IND/IDE Support Office can assist investigators with deciding if their study requires an IND or IDE.

For studies conducted under an investigator held IND or IDE, the IND/IDE Support Office can assist in protocol development.

Resources

Data Safety Monitoring Board (DSMB)
Some studies, based on factors such as the phase, population, intent of the study, intervention, may require a DSMB that would monitor patient safety and treatment efficacy data when a study is ongoing. This information is critical to study design, and would be included in the protocol. To determine whether your study may need a DSMB, please reach out to the indide [at] chop.edu (IND/IDE Support Office).

Application

Regulatory Application Process

A clinical trial that is under an IND or IDE will need approval by the FDA, IRB and all corresponding regulatory agencies. The sponsor-investigator is responsible for ensuring compliance and approval with all regulatory agencies that will provide review or oversight for the study.

Internal Review:

  • Scientific Review Committee
    Clinical IND and IDE studies sponsored by a CHOP investigator require scientific review by the IND/IDE Scientific Review Committee (SRC).
  • Investigational Drug Services (IDS)
    All investigational products are handled by CHOP’s Investigational Drug Services (IDS), unless the IDS determines otherwise. Clinical investigators should contact the IDS prior to grant and/or IRB submission to coordinate Pharmacy IDS services.
  • Office of Research Compliance (ORC)
    In addition to other critically important services, the ORC provides monitoring of studies under an investigator held IND or IDE, including a pre-trial monitoring visit, which is required prior to receiving full regulatory approval.
  • Medical Device Committee
    This committee reviews studies involving investigational devices or other devices not in use or not approved for use at CHOP. If you have a device that needs to be reviewed by the Medical Device Committee, please reach out to Richard Lin at linr [at] chop.edu (linr[at]chop[dot]edu).

External Review:

In addition to FDA and IRB approval, studies under an IND or IDE may require additional review and approval from regulatory bodies external to CHOP, based on the study design or the drug. These other regulatory groups may include, but are not limited to the Drug Enforcement Administration (DEA), Department of Health and Human Services (DHHS), and the Office of Biotechnology Activities (NIH OBA-RAC). If you have questions regarding whether your proposed study would require review from these regulatory groups, please reach out to our office. If your clinical trial may require a Certificate of Confidentiality, please visit the IRB's information on Certificate of Confidentiality.

Management

Study Start Up & Management

There are many things to take into consideration when starting and conducting a study.

The Office of Research Compliance (ORC)
The Office of Research Compliance (ORC) can provide support such as document tracking (e.g. protocol, consent), monitoring IND/IDE studies, study staff training, registering a study at Clinicaltrials.gov, essential document management, and subject case history development.

Investigational Drug Services (IDS)
CHOP’s Investigational Drug Services (IDS) handles all investigational drug products, unless the IDS determines otherwise. Clinical investigators should contact the IDS prior to grant and/or IRB submission to coordinate Pharmacy IDS services. IDS can assist the clinical investigator with a broad range of study related functions.

Data Management: OnCore & REDCap
For IND/IDE studies, OnCore or REDCap can be used for data management. For studies that require a Part 11 compliant data capture system, OnCore FORTE EDC can provide that service.For studies that do not require a Part 11 compliant data capture system, investigators may use either OnCore or REDCap.

FDA Correspondence
The IND/IDE Support Office will provide support for correspondence with the FDA. Sponsors and study teams are required to submit all FDA correspondence documentation to the IND/IDE Support Office for institutional record keeping, including but not limited to: annual reports, amendments, SAE reports, protocol deviations, IND withdrawals and study close out documentation.

Sponsor Reporting Requirements:
The IND or IDE Sponsor is responsible for reporting the following information to the FDA:

  • Protocol changes
  • Updates in information contained on the Form FDA 1572 or Investigator Agreement (i.e. changes to the study team or sites/satellites of the investigation)
  • Updates in safety information about the drug or device
  • Updates in manufacturing, controls, or results of tests conducted on the drug or device Annual reporting
  • Change in investigators or change in the Sponsor or Primary Point of Contact and/or address
  • Transfer of Obligations
  • Completion or termination of a trial (Clinical study report)
  • New trials under the IND or IDE
  • Closure or withdrawal of the IND or IDE

FDA Reporting Guidance
Visit FDA.gov and search for the most recent guidance for:

  • FDA Adverse Event Reporting Guidance
  • FDA: IDE Unanticipated Adverse Device Effects
  • FDA Final Rule: IND Safety Reporting Requirements
  • Safety Reporting Requirements for IND and bioavailability (BA) / bioequivalence (BE) studies
  • FDA: Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities

FDA IND Application Guidance
For general FDA guidance regarding IND application management and reporting requirements, visit the FDA's IND Application page.

FDA IDE Application Guidance
For general FDA guidance regarding IND application management and reporting requirements, visit the FDA's IDE Application page.

Close Out

Study Close Out

After a study is closed with the CHOP IRB and ORC has completed their final monitoring visit, Sponsors may decide to close or withdraw the IND with the FDA. This is done by submitting a close out report to the FDA. The IND/IDE Support Office can assist with drafting, reviewing, and submitting close out reports to the FDA. Sponsors may also have the option of allowing the IND to remain open with the FDA, if they wish to continue data analysis, or pursue opening a new protocol under the IND. This information would be included in the close out report that is sent to the FDA. If applicable, trial results should be posted on ClinicalTrials.govwithin 12 months of the primary completion date for the study. For assistance and guidance, please reach out to ORC at orc [at] chop.edu (orc[at]chop[dot]edu).

An IND or IDE Sponsor is the individual who submits the IND or IDE application to the FDA. Many responsibilities accompany Sponsors and Sponsor Investigators. Below are some questions to ask before pursuing an IND or IDE trial.

Ask CHOP Office of Technology Transfer

  • Do I need a Confidentiality or Non-Disclosure Agreement before talking to drug or device company/manufacturer?
  • Is a technology assessment or intellectual property management needed?

Ask the Drug or Device Company/Manufacturer:

  • Can I obtain the drug or device?
  • Will the company provide a Letter of Authorization to support the IND or IDE application?
  • Does the company intend or hope to plan to use the data to support label change?
  • How much support will the company provide? Some companies have processes on their websites for obtaining funding/support
    • Drug or device costs
    • Operational costs i.e. administrative/regulatory
    • Monitoring costs
    • Database costs
  • If the company is providing funding, a Confidential Disclosure Agreement and Clinical Trials Agreement should be in place.

Ask CHOP Investigational Drug Service

  • Do we have the capacity to store and dispense the drug?
  • Do we have the capacity to compound and test the drug for stability, sterility, and purity (if needed)

Do I have appropriate funding and resources?

  • Ask CHOP CTFM: Estimate of subject care costs
  • Ask CHOP CRSO: Estimate of operational costs

Do I know my responsibilities after opening the IND?

1. Investigator IND
2. Emergency Use IND*
3. Treatment / sINDs*
4. Information on IDEs from CHOP's IRB

* Emergency Use IND and Treatment IND/Single Subject IND are examples of single subject, expanded access INDs

In addition to Collaborative Institutional Training (CITI) training required by the CHOP IRB to conduct research at CHOP, you are also required as a CHOP sponsor or sponsor-investigator to take the CITI Good Clinical Practices modules.

Sponsors are also required to complete IND or IDE responsibilities training.