OMBGenericClearanceAttachment2-FINAL

Attachment 2. Example of Customer Satisfaction Survey

OMB No: XXX-XXXX

Expiration Date: XX/XX/20XX

Food and Drug Administration Amendments Act (FDAAA) Implementation at NIH

Survey of Grantees

Sponsored by:

National Institutes of Health

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number of this information collection is XXX-XXXX. The time required to complete this information collection is estimated to average 15 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have any comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974 Attn: PRA (XXXX-XXXX). If you have comments or concerns regarding the status of your individual submission of this form, contact: [TBD Inc., 1111 Nowhere Road, Somewhere, NJ, 11111-1111. 1-800-111-1111. Attn: TBDProject XXXX-XXXX.

Introduction

This survey of NIH grantees with trials registered in ClincalTrials.gov is to help examine NIH's implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA; http://grants.nih.gov/clinicaltrials_fdaaa/index.htm ). The objective is to improve of the certification of compliance process and enhance grantee’s understanding FDAAA’s requirements throughout the lifecycle of applicable clinical trials. This is the first annual “point in time” survey to gather grantees’ opinions about the certification of compliance with FDAAA. This information will be useful in assessing the changes introduced by NIH implementation of FDAAA and may be used to further improve the peer review process.

You have been randomly selected to participate in this survey from a pool of grantees who received NIH funds to support the conduct of clinical trials (other than Phase 1) from September 2007 to the present. We are interested in the opinions of grantees with different levels of experience with NIH-funded applicable clinical trials. Even if you have limited experience applicable clinical trials, your opinions are very important to us.

The survey should take approximately 15 minutes to complete. You can stop at any point and continue at another time. There are no right or wrong answers, so please give the answer that best describes your opinion. While we would like you to answer all the questions in this survey, you may skip any questions that you do not wish to answer.

Your participation is fully voluntary and non-participation will have no impact on eligibility for or receipt of future services. If you choose to complete the survey, your responses will remain anonymous. Your responses will not be linked to your name and will not be made known to NIH staff. Steps have been taken to ensure unbiased completion of questionnaires by use of third-party distribution and receipt by a party not directly involved in provision of the service being assessed.

Aggregate responses will be used to guide NIH management in refining its implementation of the certification of compliance with FDAAA and enhance grantee understanding of FDAAA’s requirements throughout the lifecycle of an applicable clinical trial.

Your participation is greatly appreciated.

Section A: Your Clinical Trials Experiences

1. How long have you been an NIH grantee?

__ <1 year

__ 1-5 years

__ 6-10 years

__ > 10 years

2. How many of the clinical trials for which you are key personnel are registered in ClinicalTrials.gov?

__ 1

__ 2-5

__ 6-10

__ > 10

3. Were any of the clinical trials supported by your NIH funds registered in ClinicalTrials.gov (e.g. either to meet FDAAA or as a requirement for publication in the ICJME associated journals)?

__ Yes (please continue to Question 3.)

__ No (please continue to Section B.)

4. Did any of your NIH grants support (in whole or in part) an “applicable clinical trial”?

__ Yes

__ No

5. Does your Institution provide a Protocol Registration System (PRS) organizational account for you to register your trials in ClinicalTrials.gov?

__ Yes

__ No

6. Does your Institution provide logistical support for clinical trials data analysis and results reporting to ClinicalTrials.gov?

__ Yes

__ No

7. How much time do you spend each month inputting data into ClinicalTrials.gov?

__ <1 hour

__ 1-5 hours

__ 6-10 hours

__ > 10 hours

Section B: Your Understanding of FDAAA

8. How helpful is your Institution in determining your responsibilities for compliance with FDAAA?

1-----------------------2-------------------------3------------------------4--------------------------------5

not at all helpful very helpful

9. How helpful is your NIH Program Official in explaining your responsibilities for NIH certification of compliance with FDAAA?

1-----------------------2-------------------------3------------------------4--------------------------------5

not at all helpful very helpful

10. Where do you acquire guidance on FDAAA and your clinical trials (check all that apply)?

__ Your Institution’s sponsored research office

__ NIH web sites and staff

__ FDA web sites and staff

__ Private consulting firm

__ Colleagues

11. What parts of FDAAA do you find the most challenging to understand (check all that)?

__ Identifying “applicable clinical trials”

__ Identifying the “responsible party”

__ Identifying milestones for registration and results reporting requirements

__ Inputting results

__ Inputting adverse events

__ Other (please describe): ________________________________________________

Section C: NIH Certificates of Compliance with FDAAA

12. Based on your understanding, which of the following require NIH certification of compliance with FDAAA in competing applications and/or progress reports submitted to the NIH?

__ on-going applicable clinical trials only

__ proposed applicable clinical trials only

__ both on-going and proposed applicable clinical trials

__ neither on-going and proposed applicable clinical trials

13. How much time do you spend each month on NIH certificates of compliance with FDAAA?

__ <1 hour

__ 1-4 hours

__ 5-10 hours

__ > 10 hours

14. Is the time spent on NIH certificates of compliance with FDAAA burdensome?

__ yes

__ no