Create Regulatory Binders

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Regulatory Binder

You should begin putting together a regulatory binder for your trial. The Regulatory binder is the central file for all required regulatory documents (log in required) relating to the study. The Essential Documents Checklist (log in required) provides a list of vital documents that should be kept in your regulatory binder. Regardless of the funding source, essential documents should be maintained for all research studies including minimal risk studies.

Although you may store study documents as paper copies in binders provided by the study sponsor, you have the option to store them electronically in your CHOP study drive or in Complion (log in required). The Complion application is a 21 CFR Part 11 compliant electronic document storage platform accessible to both study team members and monitors. If you use your CHOP study drive, study documents can be shared with the monitor via OneDrive.

The order of the sections can vary depending on your study, but it is generally easier to keep the most frequently used sections closer to the beginning of the binder. In many cases it may be more convenient to use more than one binder to hold all the documents. Careful labeling of the binders and an organized tabular system will keep your files well organized. All study related documents must be made available and accessible upon request of the ORC, IRB, auditors, sponsor, and regulatory agencies.

Pharmacy Binder

The pharmacy binder must be provided to the IDS Pharmacy (log in required) before the site initiation visit. The pharmacy staff will maintain the binder until study closeout. Contents of the pharmacy binder include:

  1. Drug receipt and destruction logs
  2. Certificate of analysis (CoA) from manufacturer
  3. Package insert or Manufacturing Safety Data Sheet (MSDS)
  4. Drug accountability log
  5. Drug order form
  6. Pharmacy manual
  7. Investigator's Brochure (IB) including revised versions
  8. Temperature logs
  9. Calibration logs of aseptic hoods, refrigerators or freezers
  10. Pharmacy monitoring visit log

Reference Binder and/or Standard Operating Procedures (SOPs)

It is recommended that a reference binder and/or SOPs be prepared for each of your trials. This should include specific details about all steps/process, etc. necessary to conduct your trial. In the event of your absence, another member of your team should be able to use this reference binder and/or SOP and know exactly what to do as your backup.

Use Policy Manager for finding up to date documents and resources to guide your research practice.