fast track study NLM 2021 ClinicalTrials.gov Usability Testing

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback” (OMB#: 0925-0648 Exp. Date: 05/31/2021)

T ITLE OF INFORMATION COLLECTION: 2021 NLM ClinicalTrials.gov Usability Testing Survey

PURPOSE:

The goal of this National Library of Medicine (NLM) survey is to collect qualitative customer service delivery feedback from users of the National Center for Biotechnology Information (NCBI) ClinicalTrials.gov website. NLM will conduct virtual user testing interviews to assess the usability and readability of 3 ClinicalTrials.gov webpages to ensure the information meets the needs of a general audience, including those with limited health literacy. The results of this survey will allow NLM to better understand the information that users expect to see related to clinical trials and to improve the educational information about clinical trials on the ClinicalTrials.gov website.

DESCRIPTION OF RESPONDENTS:

This usability survey will be conducted to obtain feedback from the general public who access pages at the ClinicalTrials.gov website.

TYPE OF COLLECTION: (Check one)

[ ] Customer Comment Card/Complaint Form [ ] Customer Satisfaction Survey

[X] 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: Anna M Fine, PharmD, MS

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

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? [X] Yes [ ] No

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

3. If Applicable, has a System or Records Notice been published? [ ] Yes [ ] No [X]

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [ ] Yes [X] 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
Individuals or Households (participant sign-up survey)	60	1	2/60	2
Individuals or Households (usability testing participants)	40	1	1	40
Totals	60	60		42

Category of Respondent	Total Burden Hours	Wage Rate*	Total Burden Cost
Individuals or Households	42	$25.72	$1080.24
Totals			$1080.24

* BLS May 2019 National Occupational Employment and Wage Estimates, United States

https://www.bls.gov/oes/current/oes_nat.htm#00-0000;

FEDERAL COST: The estimated annual cost to the Federal government is: $3575.00

Staff	Grade/Step	Salary	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Staff Scientist	T-42	$142,000	0.25%		$355.00
Contractor Cost
Moderator/Facilitator		$86,000	2%		$1720.00
Note-taker		$50,000	3%		$1500.00
Travel
Other Cost
Total					$3575.00

* Cited from https://ohr.od.nih.gov/intrahr/Documents/title42/NIH_TITLE_42_PAY_MODEL_RANGES.pdf

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 [X] 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?

People who are interested will click a link to answer screening questions online and then be scheduled for the user interview via Zoom or telephone.

Administration of the Instrument

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

[X] Web-based or other forms of Social Media

[X] Telephone

[ ] In-person

[ ] Mail

[ ] Other, Explain

2. Will interviewers or facilitators be used? [X] Yes [ ] No

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