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

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 1 Sabbatical in Clinical Research Management Course Evaluation	Form	Unchanged	Available
Form 1 Sabbatical in Clinical Research Management Course Evaluation (Healthcare Professionals)	Form	Unchanged	Repair queued
Form 1 NIH Summer Course in Clinical and Translational Research Course Evaluation	Form	Unchanged	Available
Form 1 NIH Summer Course in Clinical and Translational Research Course Evaluation	Form	Unchanged	Repair queued
Form 1 PCP Final Course Evaluation	Form and Instruction	Modified	Available
Form 1 PCP Final Course Evaluation (General Public)	Form and Instruction	Modified	Repair queued
Form 1 PCP Final Course Evaluation	Form and Instruction	Modified	Available
Form 1 PCP Final Course Evaluation (Students)	Form and Instruction	Modified	Repair queued
Form 1 PCP Final Course Evaluation	Form and Instruction	Modified	Available
Form 1 PCP Final Course Evaluation (Healthcare Professionals)	Form and Instruction	Modified	Repair queued
Form 1 PCP Lecture Evaluation	Form and Instruction	Modified	Available
Form 1 PCP Lecture Evaluation (General Public)	Form and Instruction	Modified	Repair queued
Form 1 PCP Lecture Evaluation	Form and Instruction	Modified	Available
Form 1 PCP Lecture Evaluation (Students)	Form and Instruction	Modified	Repair queued
Form 1 PCP Lecture Evaluation	Form and Instruction	Modified	Available
Form 1 PCP Lecture Evaluation (Healthcare Professionals)	Form and Instruction	Modified	Repair queued
Form 1 IPPCR Final Course Evaluation (Screenshot)	Form and Instruction	Modified	Available
Form 1 IPPCR Final Course Evaluation (General Public)	Form and Instruction	Modified	Repair queued
Form 1 IPPCR Final Course Evaluation	Form and Instruction	Modified	Available
Form 1 IPPCR Final Course Evaluation (Students)	Form and Instruction	Modified	Repair queued
Form 1 IPPCR Final Course Evaluation	Form and Instruction	Modified	Available
Form 1 IPPCR Final Course Evaluation (Healthcare Professionals)	Form and Instruction	Modified	Repair queued
Form 1 IPPCR Lecture Evaluation	Form and Instruction	Modified	Available
Form 1 IPPCR Lecture Evaluation (General Public)	Form and Instruction	Modified	Repair queued
Form 1 IPPCR Lecture Evaluation	Form and Instruction	Modified	Available
Form 1 IPPCR Lecture Evaluation (Students)	Form and Instruction	Modified	Repair queued
Form 1 IPPCR Lecture Evaluation	Form and Instruction	Modified	Available
Form 1 IPPCR Lecture Evaluation (Health Care Professionals)	Form and Instruction	Modified	Repair queued
Form 1 OCR Learning Portal Registration Screenshot	Form and Instruction	Modified	Available
Form 1 OCR Learning Portal Registration (General Public)	Form and Instruction	Modified	Repair queued
Form 1 OCR Learning Portal Registration Screenshot	Form and Instruction	Modified	Available
Form 1 OCR Learning Portal Registration (Students)	Form and Instruction	Modified	Missing upstream
Form 1 OCR Learning Portal Registration Screenshot	Form and Instruction	Unchanged	Available
Form 1 OCR Learning Portal Registration (Health Professionals)	Form and Instruction	Unchanged	Missing upstream
30 day 0764.pdf	Supplementary Document	Uploaded 2022-11-17	Missing upstream
OCR OMB Clearance Statement A 2022 for extension final.docx	Supporting Statement A	Uploaded 2022-11-03	Repair queued
Privacy Act Memo.pdf	Supplementary Document	Uploaded 2022-10-27	Repair queued
HHS Approved PIA form for OCR 2022.pdf	Supplementary Document	Uploaded 2022-10-27	Repair queued

IC Document Collections

Information collection document groups

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

ICR Details

OMB Control No: 0925-0764	ICR Reference No: 202210-0925-009
Status: Historical Active	Previous ICR Reference No: 201909-0925-001
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/21/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/22/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2026	36 Months From Approved	02/28/2023
Responses	22,040	0	9,540
Time Burden (Hours)	3,674	0	1,589
Cost Burden (Dollars)	0	0	0

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Abstract: The request for an extension under the existing clearance number 0925-0764 for information collection allows the ongoing 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. The information received from respondents is 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.

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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:
	87 FR 52979	08/30/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 69036	11/17/2022
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

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

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ICR Summary of Burden

table that charts list 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	22,040	9,540	0	12,500	0	0
Annual Time Burden (Hours)	3,674	1,589	0	2,085	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: There has been an adjustment in burden due to the rise in popularity of our clinical research training programs around the world. It’s led to an increasing number of participants and participant responses for our programs. Responses have increased by 12,500 and burden hours by 2,085.

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Annual Cost to Federal Government: $48,364

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? No

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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: 11/22/2022

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