Office of Human Research


  • Director, Office of Human Research
  • Director, Clinical Research Unit
  • Professor, SKMC Department of Pharmacology & Experimental Therapeutics
Contact Number(s):

For Research Activities

  • Senior Associate Provost, Research Integrity, Conduct & Compliance
  • Professor, SKMC Department of Pathology, Anatomy & Cell Biology
Contact Number(s):

Essential Study Documentation

As part of the Quality Improvement Program, the OHR offers assistance in the creation and maintaining of study/regulatory and patient binders for clinical research studies. While the Quality Improvement Team is more than happy to meet with and assist any study personnel in their documentation methods, the OHR has provided all the tools needed to create your own binder using the documents below. Documents for both study/regulatory and patient binders have been provided.

Study/Regulatory Binder Documents

Document Description
Divider Tabs (DOC) The divider tab inserts needed for the binder
Binder Section Descriptions (DOC) A sheet for each section indicating what should be stored in that section
Screening and Enrollment Log (DOCX) List of all screened/enrolled subjects
Delegation of Authority Log (DOCX) List of responsibilities assigned to each team member
Biological Specimen Tracking Log (De-identified) (DOC) De-identified tracking log for biological specimens
Biological Specimen Tracking Log (Identifiable) (DOC) Identifiable tracking log for biological specimens
Training Log (DOCX) List of training completed by team members
Unanticipated Problems Log (DOCX) List of unanticipated problems

Patient Binder Documents

Document Description
Patient Binder Contents Sheet (DOC) List of some patient binder contents
Informed Consent Checklist (DOC) Checklist to help document all aspects of the consent process
Investigational Product Accountability Log (DOC) Documents test article dispensation and return
Documentation of Subject Unblinding (DOC) Documents when a subject's treatment must be unblinded
Adverse Event Log (DOCX) List of adverse events