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Investigational pharmacy manual for investigators

Tufts Medical Center/Tufts University Health Sciences Institutional Review Board
Instructions for completing the FORM II: Pharmacy
Please note that the Tufts Medical Center Department of Pharmacy Services Investigational Drug Service (IDS) should be consulted during the development of the study and/or prior to submission of a new study to the Tufts MC/TUHS IRB. Please include the following in the heading section of each Form II: IRB #: Insert the IRB # for existing studies. Please leave this field blank for new studies that have not yet been assigned an IRB #.
Principal Investigator: Insert the Principal Investigator’s full name, including first name, last name, and degrees.
Study Title: Insert the full study title. If the study has a sponsor assigned protocol number, the protocol number can be included at
the beginning or end of the study title.
Please list each study substance and ancillary drug to be administered for research purposes in this study. The terms “drug” and “study substance” include FDA-approved prescription medications, herbal remedies, vitamins, nutraceuticals, over-the-counter drugs and dietary supplements, vaccines, diagnostic and contrast agents, as well as any test article intended to diagnose, treat, mitigate, or cure disease or discomfort. The term includes placebos, biologicals, and any drug or substance delivered onto or into the body via a device. Although the terms “drug” and “study substance” include radioactive drugs (those that emit particles or energy waves) and blood products or blood derivatives such as cells or cellular components, the Pharmacy’s IDS does not oversee the research use of these items. Contact Health Physics ((617)636-6168) when submitting a Form II for a radioactive drug or contact the Blood Bank ((617) 636-6450) when submitting a Form II for a blood product or derivative. Ancillary or supportive drugs administered in association with a protocol-required drug regimen, procedure, or test, require the submission of a Form II if the drug and dose are specified in the protocol. If such drugs are not further specified in the protocol, but are part of an otherwise routine regimen, procedure, or test that would otherwise be considered standard of care, a Form II is not needed. Please submit the following documents along with this form for each study substance, as applicable: a copy of the FDA determination/correspondence regarding the IND, PI’s letter of IND exemption attestation, the investigator’s brochure and/or composition of the placebo (if a placebo is used), and (Note: package inserts are not required to be submitted for FDA approved study substances) Complete a section for each study substance: (Please check one (1-4) and complete a. or b., as applicable) 1.  The study substance is FDA approved for the intended study population and will be administered in this study according to FDA 2.  The study substance is FDA approved, but will NOT be administered in this study according to FDA approved labeling. a.  The study substance is exempt from IND requirements stated in 21 CFR 312.2(b)(1) b.  IND # ________ has been issued to: ________ (Please submit the investigator’s brochure.) 3.  The study substance is not FDA approved. a.  IND # ________ has been issued to: _________ (Please submit the investigator’s brochure.) b.  The study substance is marketed, but not as a drug and does not require FDA approval. 5. Is the Tufts MC research pharmacy storing and preparing the drug? Insert the generic name, trade name, and supplier. i. Generic Name: Insert the name of the study substance. Generic names are sometimes based on the drug's chemical name,
structure, or formula. Examples of generic names are acetaminophen and pseudoephedrine. For non-drug substances, please insert the study substance name. ii. Trade Name: The trade name is the proprietary or advertised brand name under which the drug is sold. Trade names are
usually “catchy” and are often related to the drug's intended use. Examples of trade names are Tylenol and Benadryl. If the study substance does not have a trade name, please insert “N/A” for not applicable. iii. Supplier: The supplier is the source of the study substance. Sometimes the supplier is the manufacturer. The supplier should
Instructions for completing the FORM II (version dated 05 January 2012)
Please check 1, 2, 3, or 4 for each substance and complete a. or b., as applicable, and complete 5: 1.  The study substance is FDA approved for the intended study population and will be administered in this study according to FDA approved labeling.
Check “1” for FDA approved drugs that are being administered according to FDA approved labeling, i.e., approved indication, dose, and
frequency. This box is also applicable when administering a FDA approved pre-medication for a research procedure, e.g., the use of Tylenol,
Benadryl or hydrocortisone as premedication for a biologic therapy or the use of lidocaine for a research biopsy if the drug and dose are
specified in the protocol.
2.  The study substance is FDA approved, but will NOT be administered in this study according to FDA approved labeling. a.  The study substance is exempt from IND requirements stated in 21 CFR 312.2(b)(1) b.  IND # ______ has been issued to: ______ (Please submit the investigator’s brochure.) Check “2” for FDA approved drugs that are NOT being administered according to their FDA approved labeling, i.e., investigational indication,
dose, use of a drug in children that is FDA approved in adults only, and/or frequency.

Check “a” if the study substance is exempt from IND requirements (i – vi below).
Per 21 CFR 312.2(b)(1), the clinical investigation of a marketed drug or biologic does not require submission of an IND if all six of the (i) it is not intended to be reported to FDA in support of a new indication for use or to support any other significant change in the labeling for (ii) it is not intended to support a significant change in the advertising for the product; (iii) it does not involve a route of administration or dosage level, use in a subject population, or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product; (iv) it is conducted in compliance with the requirements for IRB review and informed consent [21 CFR parts 56 and 50, respectively]; (v) it is conducted in compliance with the requirements concerning the promotion and sale of drugs [21 CFR 312.7]; and (vi) it does not intend to invoke 21 CFR 50.24., which is the regulation on waiving informed consent requirements for emergency research For cancer studies, please also refer to this guidance:
Check “b” if the FDA has issued an IND for the use of the drug in this study. Insert the IND# and specify to whom the IND has been issued.
An IND may be issued to a company, a government agency (e.g., NIH or NCI), or an individual investigator (sponsor-investigator). Please
also submit the investigator’s brochure.
3.  The study substance is not FDA approved.
a.  IND # ______ has been issued to: ______(Please submit the investigator’s brochure.) b.  The study substance is marketed, but not as a drug and does not require FDA approval.
Check “3” for substances that are investigational and have not been approved by the FDA.

Check “a” if the FDA has issued an IND for the use of an investigational drug in this study. Insert the IND # and specify to whom the IND #
has been issued. An IND # may be issued to a company, a government agency (e.g., NIH or NCI), or an individual investigator (sponsor-
investigator). Please also submit the investigator’s brochure.

Check “b” if the study substance is marketed, but not as a drug and does not require FDA approval, for example, a vitamin, food product, or
dietary substance. Please also submit any supporting documents for the substance (substance information, publications, etc.).
4.  Other (explain): ______

Check “4” if the study substance does not fit into categories 1-3 above and explain the circumstances. Please also submit any supporting
documents for this substance (substance information, manufacturing details, growing instructions, preparation instructions, publications, etc.).
5. Is the Tufts MC research pharmacy storing and preparing the drug?
Complete 5. JCAHO regulations require that the Tufts MC Pharmacy control the storage, dispensing, labeling, and distribution of study substances intended for research purposes in Tufts MC subjects. Exceptions may be considered by the IDS for study substances that require rapid administration (e.g., in the cardiac catheterization laboratory or Emergency Department) or for study substances that are prescribed to research subjects in clinics outside of Tufts MC. Please contact the IDS with questions. There is space on each Form II to list 2 substances. Please complete additional Form IIs as needed and insert the Form II page number and total number of Form II pages at the bottom of each Form II, i.e., Form II page ____ of ____. The Principal Investigator must sign and date each Form II with an original signature. Signature stamps or electronic signatures will not be accepted. Instructions for completing the FORM II (version dated 05 January 2012)

Source: http://viceprovost.tufts.edu/HSCIRB/files/FormII_instructions.pdf

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