fast track for CREST

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback” (OMB#: 0925-0648 Expiration Date: 05/2021)

TITLE OF INFORMATION COLLECTION: NIMH Clinical Research Education, Support, and Training (CREST) Program Customer Satisfaction Survey

PURPOSE:

The purpose of this survey is to collect anonymous voluntary feedback on the NIMH CREST program. The CREST program provides ongoing educational and technical support to clinical research study teams selected for phone or email consultation, and/or site visit(s), to insure NIMH funded clinical research is conducted in compliance with all applicable laws and guidelines in place to protect study participants safety and data. The NIMH would like to collect anonymous feedback from these study teams to make sure that we are providing the best value to our customers. We consider this type of survey will allow the study teams an avenue for feedback they currently do not have, and the feedback received will be utilized to enhance the CREST program and correct areas that are not meeting our goals.

DESCRIPTION OF RESPONDENTS:

NIMH-funded researchers who interact with our CREST monitors such as the Principle Investigator, Clinical Research Coordinator, Study Nurses, Pharmacists, and other study team members.

TYPE OF COLLECTION: (Check one)

☐ Customer Comment Card/Complaint Form ☒ Customer Satisfaction Survey

☐ Usability Testing (e.g. Website or Software) ☐ Small Discussion Group

☐ Focus Group ☐ Other: __________________

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

4. The results are not intended to be disseminated to the public.

5. Information gathered will not be used for the purpose of substantially informing influential policy decisions.

6. The collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the future.

Name: Yancy Bodenstein, NIMH Clinical Trials Operations and Biostatistics Branch (CTOBB)

To assist review, please provide answers to the following questions:

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? ☐Yes ☒No

2. If Yes, is the information that will be collected included in records that are subject to the Privacy Act of 1974? ☐Yes ☐No

3. If applicable, has a System or Records Notice been published? ☐Yes ☒No

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? ☐Yes ☒No

ESTIMATED BURDEN HOURS and COSTS

Category of Respondent	No. of Respondents	No. of Responses per Respondent	Time per Response (in hours)	Total Burden Hours
Private sector - Medical Scientists	200	1	10/60	33
TOTAL		200		33

Category of Respondent	Total Burden Hours	Hourly Wage Rate*	Total Burden Cost
Medical Scientists	33	$46.36	$1,529
TOTAL			$1,529

_{*Cite source per www.bls.gov if applicable -} https://www.bls.gov/oes/current/oes191042.htm

FEDERAL COST: The estimated annual cost to the Federal government is: $253

Staff	Grade/Step	Salary	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
CTOBB Branch Chief	14/5	$132,818	1		$133
Contractor Cost
Management Analyst		$120,000	1		$120
Travel
Other Cost
TOTAL					$253

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents

1. Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting from this universe? ☒Yes ☐ No

If the answer is yes, please provide a description of both below (or attach the sampling plan)? If the answer is no, please provide a description of how you plan to identify your potential group of respondents and how you will select them?

The study team members will be identified by the email addresses used to coordinate our site visits. We obtain these emails from the NIH data system used during the grant application process.

Administration of the Instrument

1. How will you collect the information? (Check all that apply)

☒ Web-based or other forms of Social Media

☐Telephone

☐In-person

☐Mail

☐Other, Explain

2. Will interviewers or facilitators be used? ☐Yes ☒No