Application and Impact of Online Clinical Research Training Programs on Healthcare Professionals in Industry, Academia, and Clinical Research, Office of Clinical Research, OD, NIH

Forms and Documents

Document Name	Status
Form 1 Sabbatical in Clinical Research Management Course Evaluation (Healthcare Professionals) Form	New
Form 1 NIH Summer Course in Clinical and Translational Research Course Evaluation Form	New
Form 1 PCP Final Course Evaluation (General Public) Form and Instruction	New
Form 1 PCP Final Course Evaluation (Students) Form and Instruction	New
Form 1 PCP Final Course Evaluation (Healthcare Professionals) Form and Instruction	New
Form 1 PCP Lecture Evaluation (General Public) Form and Instruction	New
Form 1 PCP Lecture Evaluation (Students) Form and Instruction	New
Form 1 PCP Lecture Evaluation (Healthcare Professionals) Form and Instruction	New
Form 1 IPPCR Final Course Evaluation (General Public) Form and Instruction	New
Form 1 IPPCR Final Course Evaluation (Students) Form and Instruction	New
Form 1 IPPCR Final Course Evaluation (Healthcare Professionals) Form and Instruction	New
Form 1 IPPCR Lecture Evaluation (General Public) Form and Instruction	New
Form 1 IPPCR Lecture Evaluation (Students) Form and Instruction	New
Form 1 IPPCR Lecture Evaluation (Health Care Professionals) Form and Instruction	New
Form 1 OCR Learning Portal Registration (General Public) Form and Instruction	New
Form 1 OCR Learning Portal Registration (Students) Form and Instruction	New
Form 1 OCR Learning Portal Registration (Health Professionals) Form and Instruction	New
PIA Form for OCR.docx Supplementary Document	2019-09-25
Impact 30day.pdf Supplementary Document	2019-09-25
Privacy Act Memo.pdf Supplementary Document	2019-09-23
OCR OMB Clearance Statement A (1).docx Supporting Statement A	2019-09-16

IC Document Collections

IC ID	Document Title	Status
237845	Sabbatical in Clinical Research Management Course Evaluation (Healthcare Professionals) Form	New
237844	NIH Summer Course in Clinical and Translational Research Course Evaluation Form	New
237839	PCP Final Course Evaluation (General Public) Form and Instruction	New
237838	PCP Final Course Evaluation (Students) Form and Instruction	New
237837	PCP Final Course Evaluation (Healthcare Professionals) Form and Instruction	New
237836	PCP Lecture Evaluation (General Public) Form and Instruction	New
237812	PCP Lecture Evaluation (Students) Form and Instruction	New
237811	PCP Lecture Evaluation (Healthcare Professionals) Form and Instruction	New
237809	IPPCR Final Course Evaluation (General Public) Form and Instruction	New
237783	IPPCR Final Course Evaluation (Students) Form and Instruction	New
237763	IPPCR Final Course Evaluation (Healthcare Professionals) Form and Instruction	New
237760	IPPCR Lecture Evaluation (General Public) Form and Instruction	New
237759	IPPCR Lecture Evaluation (Students) Form and Instruction	New
237758	IPPCR Lecture Evaluation (Health Care Professionals) Form and Instruction	New
237694	OCR Learning Portal Registration (General Public) Form and Instruction	New
237693	OCR Learning Portal Registration (Students) Form and Instruction	New
237692	OCR Learning Portal Registration (Health Professionals) Form and Instruction	New

ICR Details

OMB Control No: 0925-0764	ICR Reference No: 201909-0925-001
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Application and Impact of Online Clinical Research Training Programs on Healthcare Professionals in Industry, Academia, and Clinical Research, Office of Clinical Research, OD, NIH
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/12/2019
	Date Received in OIRA: 09/26/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2022	36 Months From Approved
Responses	9,540	0	0
Time Burden (Hours)	1,589	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This request for a new clearance number for information collection allows the on-going assessment of the long-term impact and outcomes of 4 clinical research training programs provided by the Office of Clinical Research located in the NIH Office of the Director on an annual basis previously cleared under OMB#s 0925-0602 Exp. Date 9/30/2019 and 0925-0698 Exp. Date 7/31/2020. The 4 programs, the Introduction to the Principles and Practice of Clinical Research and Principles of Clinical Pharmacology, Sabbatical in Clinical Research Management, and the NIH Summer Course in Clinical and Translational Research, were formerly a part of the Office of Clinical Research Training and Medical Education in the NIH Clinical Center, but were transitioned to the NIH Office of Clinical Research, Office of the Director. The information received from respondents was evaluated annually by, and incorporated into, the ongoing operational and course improvement efforts of the Office of Clinical Research, Associate Director for Clinical Research, and the Chief Scientific Officer of the Clinical Center. The purpose of this information collection is to continue to assess the satisfaction, applicability and impact these NIH training programs have on the short- and long-term outcomes of their graduates. As the unifying office for clinical research training at NIH, it remains incumbent upon the Office of Clinical Research to assess and modify, as appropriate, its program offerings based upon trainee feedback.

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Authorizing Statute(s): EO: EO 12862 Name/Subject of EO: Setting Customer Service Standards
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 33270	07/12/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 50460	09/25/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 17

IC Title	Form No.	Form Name
PCP Final Course Evaluation (Healthcare Professionals)	1	PCP Final Course Evaluation
PCP Final Course Evaluation (General Public)	1	PCP Final Course Evaluation
IPPCR Final Course Evaluation (Healthcare Professionals)	1	IPPCR Final Course Evaluation
OCR Learning Portal Registration (General Public)	1	OCR Learning Portal Registration Screenshot
PCP Final Course Evaluation (Students)	1	PCP Final Course Evaluation
OCR Learning Portal Registration (Students)	1	OCR Learning Portal Registration Screenshot
OCR Learning Portal Registration (Health Professionals)	1	OCR Learning Portal Registration Screenshot
NIH Summer Course in Clinical and Translational Research Course Evaluation	1	NIH Summer Course in Clinical and Translational Research Course Evaluation
Sabbatical in Clinical Research Management Course Evaluation (Healthcare Professionals)	1	Sabbatical in Clinical Research Management Course Evaluation
PCP Lecture Evaluation (General Public)	1	PCP Lecture Evaluation
IPPCR Final Course Evaluation (Students)	1	IPPCR Final Course Evaluation
IPPCR Lecture Evaluation (Health Care Professionals)	1	IPPCR Lecture Evaluation
IPPCR Lecture Evaluation (Students)	1	IPPCR Lecture Evaluation
IPPCR Lecture Evaluation (General Public)	1	IPPCR Lecture Evaluation
IPPCR Final Course Evaluation (General Public)	1	IPPCR Final Course Evaluation (Screenshot)
PCP Lecture Evaluation (Healthcare Professionals)	1	PCP Lecture Evaluation
PCP Lecture Evaluation (Students)	1	PCP Lecture Evaluation

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	9,540	0	0	9,540	0	0
Annual Time Burden (Hours)	1,589	0	0	1,589	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection request.

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Annual Cost to Federal Government: $41,844

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 09/26/2019

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