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 Survey	Form	New	Available
Form 1 Ethical and Regulatory Aspects of Clinical Research (Asynchronous/Online) Course	Form	New	Repair queued
Form 1 Survey	Form	Modified	Available
Form 1 Sabbatical in Clinical Research Management Course Evaluation (Healthcare Professionals)	Form	Modified	Repair queued
Form 1 Survey	Form	Modified	Available
Form 1 NIH Summer Course in Clinical and Translational Research Course Evaluation	Form	Modified	Repair queued
Form 1 Survey	Form	Modified	Available
Form 1 PCP Final Course Evaluation (General Public)	Form and Instruction	Modified	Repair queued
Form 1 Survey	Form	Modified	Available
Form 1 PCP Final Course Evaluation (Students)	Form and Instruction	Modified	Repair queued
Form 1 Survey	Form	Modified	Available
Form 1 PCP Final Course Evaluation (Healthcare Professionals)	Form and Instruction	Modified	Repair queued
Form 1 Survey	Form	Modified	Available
Form 1 PCP Lecture Evaluation (General Public)	Form	Modified	Repair queued
Form 1 Survey	Form	Modified	Available
Form 1 PCP Lecture Evaluation (Students)	Form	Modified	Repair queued
Form 1 Survey	Form	Modified	Available
Form 1 PCP Lecture Evaluation (Healthcare Professionals)	Form	Modified	Repair queued
Form 1 Evaluation	Form	Modified	Available
Form 1 IPPCR Final Course Evaluation (General Public)	Form	Modified	Repair queued
Form 1 Evaluation	Form	Modified	Available
Form 1 IPPCR Final Course Evaluation (Students)	Form	Modified	Repair queued
Form 1 Evaluation	Form	Modified	Available
Form 1 IPPCR Final Course Evaluation (Healthcare Professionals)	Form	Modified	Repair queued
Form 1 Evaluation	Form	Modified	Available
Form 1 IPPCR Lecture Evaluation (General Public)	Form	Modified	Repair queued
Form 1 Evaluation	Form	Modified	Available
Form 1 IPPCR Lecture Evaluation (Students)	Form	Modified	Repair queued
Form 1 Evaluation	Form	Modified	Repair queued
Form 1 IPPCR Lecture Evaluation (Health Care Professionals)	Form	Modified	Repair queued
Form 1 Registration	Form	Modified	Available
Form 1 OCR Learning Portal Registration (General Public)	Form	Modified	Repair queued
Form 1 Registration	Form	Modified	Available
Form 1 OCR Learning Portal Registration (Students)	Form	Modified	Repair queued
Form 1 Registration	Form	Modified	Available
Form 1 OCR Learning Portal Registration (Health Professionals)	Form	Modified	Repair queued
OCR OMB Clearance Statement A 23_24 for REVISION.docx	Supporting Statement A	Uploaded 2024-05-24	Repair queued
HHS Approved PIA form for OCRECO.pdf	Supplementary Document	Uploaded 2024-05-24	Repair queued
OIR Privacy Act Memo 2024.pdf	Supplementary Document	Uploaded 2024-05-24	Repair queued
30-day OIR.pdf	Supplementary Document	Uploaded 2024-05-24	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
267948	Ethical and Regulatory Aspects of Clinical Research (Asynchronous/Online) Course	Form	New	Survey
267948	Ethical and Regulatory Aspects of Clinical Research (Asynchronous/Online) Course	Form	New
237845	Sabbatical in Clinical Research Management Course Evaluation (Healthcare Professionals)	Form	Modified	Survey
237845	Sabbatical in Clinical Research Management Course Evaluation (Healthcare Professionals)	Form	Modified
237844	NIH Summer Course in Clinical and Translational Research Course Evaluation	Form	Modified	Survey
237844	NIH Summer Course in Clinical and Translational Research Course Evaluation	Form	Modified
237839	PCP Final Course Evaluation (General Public)	Form	Modified	Survey
237839	PCP Final Course Evaluation (General Public)	Form and Instruction	Modified
237838	PCP Final Course Evaluation (Students)	Form	Modified	Survey
237838	PCP Final Course Evaluation (Students)	Form and Instruction	Modified
237837	PCP Final Course Evaluation (Healthcare Professionals)	Form	Modified	Survey
237837	PCP Final Course Evaluation (Healthcare Professionals)	Form and Instruction	Modified
237836	PCP Lecture Evaluation (General Public)	Form	Modified	Survey
237836	PCP Lecture Evaluation (General Public)	Form	Modified
237812	PCP Lecture Evaluation (Students)	Form	Modified	Survey
237812	PCP Lecture Evaluation (Students)	Form	Modified
237811	PCP Lecture Evaluation (Healthcare Professionals)	Form	Modified	Survey
237811	PCP Lecture Evaluation (Healthcare Professionals)	Form	Modified
237809	IPPCR Final Course Evaluation (General Public)	Form	Modified	Evaluation
237809	IPPCR Final Course Evaluation (General Public)	Form	Modified
237783	IPPCR Final Course Evaluation (Students)	Form	Modified	Evaluation
237783	IPPCR Final Course Evaluation (Students)	Form	Modified
237763	IPPCR Final Course Evaluation (Healthcare Professionals)	Form	Modified	Evaluation
237763	IPPCR Final Course Evaluation (Healthcare Professionals)	Form	Modified
237760	IPPCR Lecture Evaluation (General Public)	Form	Modified	Evaluation
237760	IPPCR Lecture Evaluation (General Public)	Form	Modified
237759	IPPCR Lecture Evaluation (Students)	Form	Modified	Evaluation
237759	IPPCR Lecture Evaluation (Students)	Form	Modified
237758	IPPCR Lecture Evaluation (Health Care Professionals)	Form	Modified	Evaluation
237758	IPPCR Lecture Evaluation (Health Care Professionals)	Form	Modified
237694	OCR Learning Portal Registration (General Public)	Form	Modified	Registration
237694	OCR Learning Portal Registration (General Public)	Form	Modified
237693	OCR Learning Portal Registration (Students)	Form	Modified	Registration
237693	OCR Learning Portal Registration (Students)	Form	Modified
237692	OCR Learning Portal Registration (Health Professionals)	Form	Modified	Registration
237692	OCR Learning Portal Registration (Health Professionals)	Form	Modified

ICR Details

OMB Control No: 0925-0764	ICR Reference No: 202402-0925-002
Status: Historical Active	Previous ICR Reference No: 202210-0925-009
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/31/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/25/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2027	36 Months From Approved	02/28/2026
Responses	21,290	0	22,040
Time Burden (Hours)	1,774	0	3,674
Cost Burden (Dollars)	0	0	0

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Abstract: The request for a revision under the existing clearance number 0925-0764 for information collection will continue to allow the assessment of the long-term impact and outcomes of clinical research training programs provided by the Office of Clinical Research Education and Collaboration Outreach (OCRECO), located in the NIH Office of Intramural Research on an annual basis. This revision request will also allow for the addition of a new clinical research training course to be delivered online through the same online learning management system as the other courses. The clinical research training programs include: the Introduction to the Principles and Practice of Clinical Research and Principles of Clinical Pharmacology, Sabbatical in Clinical Research Management, the NIH Summer Course in Clinical and Translational Research, and the new course, the Ethical and Regulatory Aspects of Clinical Research Course (Asynchronous/Online). Please note that the Office of Clinical Research Education and Collaboration Outreach (OCRECO) was formerly titled the Office of Clinical Research, until March 2023 with the change of office leadership.

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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:
	88 FR 49472	07/31/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 44999	05/22/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 18

table that charts list of burden

IC Title	Form No.	Form Name
Ethical and Regulatory Aspects of Clinical Research (Asynchronous/Online) Course	1	Survey
IPPCR Final Course Evaluation (General Public)	1	Evaluation
IPPCR Final Course Evaluation (Healthcare Professionals)	1	Evaluation
IPPCR Final Course Evaluation (Students)	1	Evaluation
IPPCR Lecture Evaluation (General Public)	1	Evaluation
IPPCR Lecture Evaluation (Health Care Professionals)	1	Evaluation
IPPCR Lecture Evaluation (Students)	1	Evaluation
NIH Summer Course in Clinical and Translational Research Course Evaluation	1	Survey
OCR Learning Portal Registration (General Public)	1	Registration
OCR Learning Portal Registration (Health Professionals)	1	Registration
OCR Learning Portal Registration (Students)	1	Registration
PCP Final Course Evaluation (General Public)	1	Survey
PCP Final Course Evaluation (Healthcare Professionals)	1	Survey
PCP Final Course Evaluation (Students)	1	Survey
PCP Lecture Evaluation (General Public)	1	Survey
PCP Lecture Evaluation (Healthcare Professionals)	1	Survey
PCP Lecture Evaluation (Students)	1	Survey
Sabbatical in Clinical Research Management Course Evaluation (Healthcare Professionals)	1	Survey

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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	21,290	22,040	0	-750	0	0
Annual Time Burden (Hours)	1,774	3,674	0	-1,900	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: Yes

Burden Reduction Due to: Changing Forms

Short Statement: Survey instruments included in this revision request have revised survey questions as well as a new survey altogether to account for the addition of a new clinical research training course, the Ethical and Regulatory Aspects of Clinical Research (Asynchronous/Online) course. The total estimated number of respondents per year to all surveys included in this request is less than the previous number cited in the extension request (22,040 respondents) based on 2023 program data. The maximum time allotment for completion of each survey was also changed from 10 minutes to 5 minutes. The estimated total burden hours requested in this current revision is 1,774 as opposed to the estimation of 3,674 burden hours in the previous extension request.

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Annual Cost to Federal Government: $52,165

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: 06/25/2024

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