Investigational Drug Study Registry Form
Department of Pharmaceutical & Nutrition Care
The Nebraska Medical Center
University of Nebraska Medical Center
To maintain compliance with The Nebraska Medical Center Department of Pharmaceutical & Nutrition Care policy
1.380, the Pharmacy and Therapeutics Committee of the Medical Staff requires that this registry form be
completed for any drug study protocol involving human subjects (volunteers or patients) at The Nebraska Medical
Center/UNMC/UNMC-P. The Pharmacy and Therapeutics Committee will review this form along with the study
protocol and then make recommendations to the Quality Assurance Committee, the Institutional Review Board
(IRB) and the Medical Staff Executive Committee.
Please Type All Applicable Information (Type N/A if Not Applicable)
IRB #: Click here to enter text.
Name of Medication: Click here to enter text.
(One form per medication)
Study Title: Click here to enter text.
Principal Investigator: Click here to enter text.
Coordinator: Click here to enter text.
Phone: Click here to enter text.
Phone: Click here to enter text.
Please choose the appropriate box(es):
This medication is provided to this institution from the sponsor
Not an FDA approved medication (investigational drug)— Please complete sections 1 and 3
An FDA approved medication, but supplied by sponsor at no charge to patient—Please complete
sections 1 and 2
This is an FDA approved medication which is available commercially (utilizing hospital supply)—Please
complete sections 1 and 2
SECTION #1—GENERAL INFORMATION
1. Nature or Purpose of Study (briefly describe): Click here to enter text.
2. Drug name: Click here to enter text.
3. Other drug names (i.e. Trade or Generic): Click here to enter text.
4. Study dosage form; include strength, concentration, and volume if applicable (i.e. 100 mg/5 mL vial or 500
mg caps/100 per bottle): Click here to enter text.
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5. Dose and treatment regimen: Click here to enter text.
6. Route of Administration:
IV
Oral
SQ
IM
ID
Other, please specify: Click here to enter text.
7. Personnel Approved to Administer Drug:
Principal or Co-Investigators
Nursing Staff
Medical House Officers
Patient (Self-Administration)
Other, please Specify: Click here to enter text.
8. Where will the investigational drug be administered:
Hospitalized inpatients, please specify (i.e. Onc/Hem, ED, ICU, OR): Click here to enter text.
Clinic outpatients, please specify clinic (i.e. CRC, Internal Med, Peds): Click here to enter text.
Lied, Village Pointe, or Bellevue Infusion Center
Other, please specify: Click here to enter text.
9. Source of drug supply:
Sponsor, please specify: Click here to enter text.
National Cancer Institute (NCI)
Department of Pharmaceutical Services
Other, please specify: Click here to enter text.
10. Pharmaceutical Services Billed To:
Grant/Contract Account #: Click here to enter text.
Investigator/Departmental Account #: Click here to enter text.
Patient (must be specified in Informed Consent Form)
Please skip questions #11-15 if oral medication OR FDA approved marketed drug
11. Stability after reconstitution (expiration): Click here to enter text.
12. If IV medication is diluted further after reconstitution:
a. What IV solution(s) may be used, including the amount of diluents used prior to administration: Click
here to enter text.
b. Min/Max allowable concentrations: Click here to enter text.
c. Special Considerations: Click here to enter text.
13. Rate of Administration: Click here to enter text.
14. Special instructions for reconstitution/administration: Click here to enter text.
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15. In-line filter required?
Yes, size: Click here to enter text.
Not required but may be used, size: Click here to enter text.
No, not allowed
SECTION #2—GENERAL INFORMATION ABOUT FDA APPROVED MEDICATION
16. Approved therapeutic indications: Click here to enter text.
17. Special precautions/warnings: Click here to enter text.
Section #3—ADDITIONAL INFORMATION FOR INVESTIGATIONAL NON-FDA APPROVED MEDICATIONS
Please be specific and include as much pertinent information as possible
18. Clinical lab tests indicated before administration: Click here to enter text.
19. Defined Drug-Drug and Drug-Lab interactions: Click here to enter text.
20. Defined Side Effects/Toxicities: Click here to enter text.
21. Use in pregnancy: Click here to enter text.
22. Pediatric use: Click here to enter text.
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