Instructions for Completing the IRB-1AProtocol Application Form

February 2008

The Office of Research Compliance has revised the IRB-1ADrug, Device, Biological Agent, Proprietary Product Supplemental report form. The most significant change involves the removal of the form field text boxes. This has been a source of frustration for investigators because the form fields were difficult to edit and spell check. In response to investigator concerns, the form fields have been removed and replaced with tables where applicable. The form is now a fully editable Word document and is capable of tracking changes. The form is no longer a protected document. See below for instructions pertaining to the new forms.

IMPORTANT - Please review the following as you prepare the protocol application:

  • So that the IRB can properly process your submission quickly and efficiently, please attach the IRB Face Page available at
  • The form now uses the underscore key “___” as a guide for where to provide certain requested information. In cases where the underscore key is used to indicate Yes/No, please erase the underscore and place an “X” next to Yes or No. In cases where the underscore key is used to indicate where to place requested information, please erase the underscore and type in the requested information.
  • Now that the form fields have been removed, please place your response below each item’s description.

Please note that the IRB WILL NOT return an application form because the text was not placed in the right spot; however, the removal of the form fields is going to make reviewing the application more challenging so we ask that these general guidelines be followed to the extent possible.

  • DO NOT submit a handwritten application.
  • Finally, please DO NOT remove or alter sections of the form that may not be applicable to your study (i.e. do not submit a protocol application with section II deleted if your study is not funded). The document must be provided to the IRB intact. If a section is not applicable to the research, please put “N/A” in that answer section.
  • DELETE this instruction page from the template in the final document.

Please contact the Office of Research Compliance at 6-8802/0986 with any questions, concerns or complaints.

(IRB-1A) Drug/Device/Biological Agent/Proprietary Product

Supplemental Form

Institutional Review Board, Research Compliance Services

Please complete this form if the proposed study involves the use of FDA approved drugs/devices, non-medical devices, investigational drugs/devices, biological agents, or proprietary products. This form must be attached to the protocol application when submitted for initial IRB review.

Principal Investigator:

Student Investigator:

Study Title:

DRUGS

1. Does the study involve the use of an FDA approved drug? ___ Yes ___ No

(If yes, list the drug name and manufacturer. If yes, YOU MUST ANSWER QUESTIONS 10-12.)

Drug Name / Manufacturer / Dosage / Route of Administration

2. Will the drug be used in accordance with manufacturer’s labeling? ___ Yes ___ No

(If no, please describe how the use will differ from manufacturer’s instructions, i.e., dosage, route of administration, etc. Please note that Investigational New Drug (IND) application may be required.)

3. Does the study involve the use of an Investigational New Drug (IND)? ___ Yes ___ No

(If yes, state the IND name, number, drug manufacturer and provide the rationale for choosing the drug dose. If yes, YOU MUST ANSWER QUESTIONS 10-12.)

Drug Name / Number / Manufacturer / Dosage / Route of Admin. / Reason/Rationale

DEVICES

4. Does the study involve the use of an FDA approved medical device? ___ Yes ___ No

(If yes, list the device name and manufacturer.)

Device Name / Manufacturer

5. Will the device be used in accordance with manufacturer’s labeling? ___ Yes ___ No

(If no, please describe how the use will differ from manufacturer’s instructions. Please note that an Investigational Device Exemption (IDE) may apply.)

6. Does the study involve the use of a non-medical device? ___ Yes ___ No

A non-medical device is one that cannot interact chemically with the body and it is not being studied or promoted for a medical purpose.

(If yes, list the device name and manufacturer.)

Device Name / Manufacturer

7. Does the study involve the use of an Investigational Device? ___ Yes ___ No

(If yes, state the IDE name, number, device manufacturer and provide the rationale for using the device.)

Device Name / Number / Manufacturer / Reason/Rationale

BIOLOGICAL AGENTS

8. Does the study involve the use of biological agents? ___ Yes ___ No

(If yes, describe its physical appearance (whether it is supplied in powder, capsule, tablet or liquid form) and the name of the licensed manufacturer including state/province and country.If yes, YOU MUST ANSWER QUESTIONS 10-12.)

Biological Agent / PhysicalState / Manufacturer / State/Province & Country

PROPRIETARY PRODUCTS

9. Does the study involve the use of a proprietary product? ___ Yes ___ No

(If yes, state the product name and manufacturer and list the individual components, dosage and route of administration. If yes, YOU MUST ANSWER QUESTIONS 10-12.)

Drug Name / Manufacturer / Dosage / Route of Admin.

DESCRIPTION OF PROCEDURES

10. Detail the administration of the medication therapy. Consideration should be given to the following sections:

10(a). Clearly explain the timing of the drug/biological administration. Include the dosing schedules and dose parameters (i.e. detail calculations including contributory factors such as, body weight and surface area).

10(b). For drug/biological administration by artery, vein, peritoneum, etc., state the mode of administration with respect to time (e.g. IV over 6 hours, constant infusion over 24 hours, etc.). Indicate preferred diluents and volume to be used. Indicate appropriate supportive care should extravasation occur. State the preferred order of administration if regimen involves multiple drug/biologicals administered subsequently.

10(c). Define duration of therapy including treatment stopping points and explain how to proceed when this point is reached. Explain transition from IV to PO administration of therapy.

11. Indicate any adverse reactions or toxicities that may be expected. Indicate the nature and the timing of the toxicity (e.g. leukopenia usually occurs between 9-14 days).

12. Include instructions for management of toxicity and how this will be monitored.

Please note the following:

The “Data Safety Monitoring” section of the IRB-1 must be completed for all studies involving the use of drugs, devices, biological agents or proprietary products.

If this is a treatment study, the IRB 1-C form must also be completed and submitted.

IRB-1A Drug/Device Supplement, Version 6/20141