PROTOCOL FORM / RESEARCH DESCRIPTION

If an item does not apply to your research project, indicate that the question is "not applicable” – do not leave sections blank

Click once on the highlighted entry in each box to provide your response. Click the item number/letter or word, if hyperlinked, for detailed instructions for that question. If your response requires inserting a table, picture, etc, you may need to first delete the box that surrounds the answer and then insert your table or other special document.

1. Purpose and objectives. List the purpose and objectives:
Insert purpose, objectives and research questions/hypotheses here. If you cut and paste from another document, make sure the excerpted material answers the question

2. Background. Describe past experimental and/or clinical findings leading to the formulation of your study. For research involving investigational drugs, describe the previously conducted animal and human studies. For research that involves FDA approved drugs or devices, describe the FDA approved uses of this drug/device in relation to your protocol. Attach a copy of the approved labeling as a product package insert or from the Physician’s Desk Reference. You may reference sponsor’s full protocol or grant application (section number and/or title) or if none, ensure background includes references. Please respond to all components of this item, or clearly indicate which components are not applicable.
Background
Describe here or you may reference sponsor protocol or grant application by section

Current practice
Only for research involving a treatment intervention, describe the current local practice - what are the alternative treatments or procedures?

3. Study Design. Describe the study design (e.g., single/double blind, parallel, crossover, etc.) Consider inserting a scheme to visually present the study design.
Describe here. If you cut and paste from sponsor's protocol or grant application make sure the excerpted material answers the question

4. Research Plan / Description of the Research Methods:
4.a. Provide a comprehensive narrative describing the research methods. 1) Provide the order in which tests/procedures will be performed, 2) Provide the setting for these events and a description of the methods used to protect privacy during the study. 3) Provide the plan for data analysis (include as applicable the sample size calculation) Please respond to all components of this item, or clearly indicate which components are not applicable.
[Describe the order in which test/procedures will be performed and a description of the setting here] [Describe the plan for data analysis here - address anayalysis for each specific aim] [Describe the rationale for determining sample size here]

4.b. List of the study intervention(s) being tested or evaluated under this protocol
N/A - this study does not test or evaluate an intervention. Skip to item 4.d.
#	Study intervention(s) being tested or evaluated under the protocol Add or delete rows as needed	Affiliate Place a check next to institution(s) where the intervention will be performed	Local Standard Practice? Indicate whether the intervention is considered acceptable practice locally for applicable institutions
1	Insert study intervention 1 here	☐ UTSW	☐ Yes
☐ PHHS	☐ Yes
☐CMC	☐ Yes
☐THR	☐ Yes
☐TSRH	☐ Yes
☐ Other: _____	☐ Yes
2	Insert study intervention 2 here	☐ UTSW	☐ Yes
☐ PHHS	☐ Yes
☐CMC	☐ Yes
☐THR	☐ Yes
☐TSRH	☐ Yes
☐ Other: _____	☐ Yes

4.c. Risk:Benefit Analysis of study interventions being tested or evaluated under this protocol For each study intervention identified in section 6b above, complete a risk:benefit analysis table. (Two tables are provided, copy & paste additional tables as needed or delete both tables if this study does not test an intervention)

4.c. Study Intervention #1 Insert name used in 4.b.
List each group exposed to this intervention on a separate line. (e.g., experimental, control, Arm A, Arm B, etc) Or state All Groups/Subjects	For each group, list the benefits of this intervention. (Benefits can be directly from the intervention or from a monitoring procedure likely to contribute to the subject’s well being). If there are no benefits, state “none”.
If you are requesting a Waiver of Informed Consent, complete the table below. If you have a consent form, list the reasonably foreseeable risks in the consent form (and do not complete this section). List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious). (include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms) Do not delete frequency. Frequency must be estimated because it will assist you with determining which adverse events will require prompt reporting.
Not serious	Serious
Likely These risks are expected to occur in more than 20 out of 100 subjects.
Not serious	Serious
Less likely These risks are expected to occur in 5-20 subjects or less out of 100 subjects.
Serious
Rare These risks are expected to occur in less than 5 subjects out of 100

4.c. Study Intervention #1 Insert name used in 4.b.
List each group exposed to this intervention on a separate line. (e.g., experimental, control, Arm A, Arm B, etc) Or state All Groups/Subjects	For each group, list the benefits of this intervention. (Benefits can be directly from the intervention or from a monitoring procedure likely to contribute to the subject’s well being). If there are no benefits, state “none”.
If you are requesting a Waiver of Informed Consent, complete the table below. If you have a consent form, list the reasonably foreseeable risks in the consent form (and do not complete this section). List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious). (include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms) Do not delete frequency. Frequency must be estimated because it will assist you with determining which adverse events will require prompt reporting.
Not serious	Serious
Likely These risks are expected to occur in more than 20 out of 100 subjects.
Not serious	Serious
Less likely These risks are expected to occur in 5-20 subjects or less out of 100 subjects.
Serious
Rare These risks are expected to occur in less than 5 subjects out of 100

4.d. List ALL other research procedures or components not listed in table 4.b. The combination of Tables 4b and 4d should account for all of the research procedures that will take place during this study. Consider grouping similar procedures under a single component (e.g., blood work, CT = safety assessments)
#	Research component individual procedures example: Eligibility Assessments History and physical Questionnaire Laboratory tests Add or delete rows as needed	Column A Local Standard Practice Indicate the number of times each procedure will be performed as stipulated in the research plan that would be performed if the participant were not participating in the study.	Column B Research Only Indicate the number of times each procedure will be performed solely for research purposes (meaning that the participant would not undergo the same number of procedures or would not undergo the procedure(s) at the same frequency if they were not participating in the study)	Column D Risks If you are requesting a Waiver of Informed Consent, complete the table below. List the reasonably expected risks for each procedure or group of procedures under the following categories as appropriate: Serious and likely; Serious and less likely; Serious and rare; Not serious and likely; Not serious and less likely
1	Insert component 1 here
Insert procedure here
Insert procedure here
Insert procedure here
2	Insert component 2 here
Insert procedure here
Insert procedure here
Insert procedure here
3	Insert component 3 here
Insert procedure here
Insert procedure here
Insert procedure here
4	Insert component 4 here
Insert procedure here
Insert procedure here
Insert procedure here

5. Safety Precautions. (Describe safeguards to address the serious risks listed above.)
a. Describe the procedures for protecting against or minimizing any potential risks for each of the more than minimal risk research procedures listed above.
Describe here
b. Where appropriate, discuss provisions for ensuring necessary medical or professional intervention in the event of adverse events, or unanticipated problems involving subjects.
Describe here
c. Will the safeguards be different between/among groups?
Yes	No
If yes, describe here