NIH Fast Track Approval Request_NLM TrainTheTrainer Survey[1]

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback”

(OMB Control Number: 0925-0648 Exp. Date: 1/15)

TITLE OF INFORMATION COLLECTION: ClinicalTrials.gov Results Database Train-the-Trainer Workshop Feedback Survey

PURPOSE:

The ClinicalTrials.gov Results Database Train-the-Trainer Workshop (“Workshop”) is designed to provide training to key personnel who are involved in submitting summary results information to ClinicalTrials.gov for their organization. This survey would be administered after participants have completed the Workshop. The purpose of the survey is to measure

1. participants’ level of satisfaction with the format and length of the workshop,

2. participants’ exposure to new information about ClinicalTrials.gov,

3. how equipped participants feel to assist members of their own organization with questions related to the Results Database

In addition, the survey is designed to collect general feedback such as participants’ likes and dislikes, what additional questions they may have and what additional resources would they have found helpful. This information will be used internally to improve on future Train-the-Trainer Workshops, and the resources generally available to ClinicalTrials.gov users.

DESCRIPTION OF RESPONDENTS:

The respondents will be Train-the-Trainer Workshop attendees, who are personnel responsible for providing ClinicalTrials.gov training and support to others at their institution/company/organization.

TYPE OF COLLECTION: (Check one)

[ ] Customer Comment Card/Complaint Form [X] 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: Heather Dobbins, LHC/NLM/NIH_________________________________

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, 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 [X] No

BURDEN HOURS

Category of Respondent	No. of Respondents	Participation Time (in hrs.)	Burden (in hrs.)
Private Sector	90	12/60	18

FEDERAL COST: The estimated annual cost to the Federal government is _$790 (the only cost is based on the approximate amount of time for ClinicalTrials.gov staff to compile the results).

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?

We will provide the survey for all of the ClinicalTrials.gov Train-the-Trainer Workshop attendees.

Administration of the Instrument

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

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

[ ] Telephone

[ ] In-person

[ ] Mail

[ ] Other, Explain

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

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