NLM NCBI ClinicalTrials.gov Website User Survey

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback” (OMB Control Number: 0925-0648)

TITLE OF INFORMATION COLLECTION:

NLM NCBI ClinicalTrials.gov Website User Survey

PURPOSE:

The purpose of this National Library of Medicine (NLM) survey is to collect qualitative customer service delivery information from users of The National Center for Biotechnology Information (NCBI) ClinicalTrials.gov website. This website provides detailed information on publicly and privately supported clinical studies of human participants conducted around the world. The purpose of this survey will to better understand our users’ needs and iteratively improve the website to better meet those needs.

DESCRIPTION OF RESPONDENTS:

The respondents will be a representative sample of users of the ClinicalTrials.gov website who are largely scientists/researchers, but may also include software engineers, medical professionals, and other members of the public

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 [X] Other: Interview

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: Justin Koufopoulos

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

Personally Identifiable Information:

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

2. If Yes, will any information that is collected be included in records that are subject to the Privacy Act of 1974? N/A

3. If Yes, has an up-to-date System of Records Notice (SORN) been published? N/A

Gifts or Payments:

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

ESTIMATE 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	1000	1	45/60	750
Totals		1000		750

Category of Respondent	Total Burden Hours	Wage Rate*	Total Burden Cost
Private Sector (Medical Scientists)	1000	$45.68	$45680.00
Totals	1000		$45680.00

*BLS May 2016 National Occupational Employment and Wage Estimates

Medical Scientists https://www.bls.gov/oes/current/oes191042.htm

FEDERAL COST: The estimated annual cost to the Federal government is $14,160

Staff	Grade/Step	Salary	% of Effort	Fringe (if applicable)	Total Cost to Gov’t
Federal Oversight
Presidential Innovation Fellow	15/2	$136,160	10.4%		$14,160
Contractor Cost					N/A
Travel					N/A
Other Cost					N/A
Total					$14,160

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

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? [X ] Yes [ ] No

Respondents will be identified by producing a list of email addresses for a representative sample of the ClinicalTrials.gov website users by generating a pop-up for a random draw of users who complete a specific sequence of pages. We expect to create an initial list of 1000 respondents to the screener/survey.

Administration of the Instrument

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

[ ] 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

3