New Protocol Applicationversion February 2025

Full study title*

Principal Investigator*

include credentials and department

Email contact*

Email address for PI or knowledgeable designee

Study team details

Key Study Personnel*

include credentials and departments for each

These individuals are required to complete CITI training prior to participating in the conduct of research.

Conflict of Interest*

Select or enter value

External site collaborators

Include credentials and email address contact information

External site IRB approval

Be sure to include documentation that supports the selection

Select or enter value

Study details

Is this a clinical trial?*

Select or enter value

Is the radiation use beyond standard of care?*

Select or enter value

Other agents use

Does this study utilize agents that pose a significant risk to the health or the environment including recombinant DNA, gene transfer to human, microorganisms, viruses, and biological toxins?

Select or enter value

Business Intelligence services needed?*

Select or enter value

Funding and sponsorship*

Select or enter value

explanation*

Research sites*

Select or enter value

other, specify

Drug study

Is/are the drug(s) FDA approved for the indication(s) described in the protocol?

1)Yes - provide FDA documentation

2) No, see IND waiver requirements

3) Both, identify drug categories below

Drug details, per above

Specify:

1) Drug name(s)

2) Drug manufacturer(s)

3) Commercial and/or experimental status

4) IND number (when applicable)

5) IND holder (when applicable)

6) Upload Investigator's Brochure (when applicable)

For compassionate drug requests only

Ensure ALL of the following:

1)Permission from the drug manufacturer has been obtained for this proposed use - a letter of authorization (or email) to cross reference the IND * is sufficient. Documentation is provided.

2)A brief clinical history of the patient including the diagnosis, disease status, prior therapy, response to prior therapy, and the rationale for requesting the proposed treatment is provided with this request.

3)The proposed treatment plan including the dose, route, duration, monitoring procedures and modifications for toxicity are included with this request.

4)A proposal specific informed consent document is included with this request.

Device details*

Is the device FDA approved for the use described in the protocol?

1) Yes - upload FDA documentation in submission

2) No - advise of IDE number and holder (as applicable)

IDE details per above

Device category and risk assessment*

select all that apply

1)category A - investigational, innovation device, not previously approved

2)category B - non-investigational, proven technology, new application

3)significant risk

4)non-significant risk

For compassionate device requests only

Ensure and provide documentation of ALL of the following:

1) Permission from the device manufacturer or sponsor has been obtained for the proposed use - a letter of authorization (or email) to cross reference the IDE * is sufficient. Documentation is provided.

2) FDA concurrence with proposed use is included in this request.

3) A brief clinical history of the patient including diagnosis, disease status, prior therapy, response to prior therapy, and the rationale for requesting the proposed treatment is included in this request.

4) The proposed treatment plan is included in this request.

5) A proposal specific informed consent document is included with this request.

For HUD/HDE requests only

*Ensure submission specifies device name(s) and FDA HDE number(s)

Attach documentation to address each item below (as applicable)

Other, specify per above

INFORMED CONSENT

Consent type

1) written - see Basic and Additional Elements of Consent document on our website at www.piedmont.org/research/

research-eforms-and-systems

2) oral - complete and include the Request for Waiver of Documentation of Informed Consent document form on our

website

3) waiver or alteration - complete and include the Alterations or Waiver of Informed Consent document form on our

website

Consent details

Below, describe the informed consent process and how capacity to consent will be assessed.

Protected Health Information (PHI) and HIPAA

In general, PHI is needed to identify eligible subjects and to conduct the study. To obtain that information authorization is required.

1) Full - complete and include the HIPAA Authorization form found on our website

2) Partial Waiver - complete and include the Alteration/Waiver of HIPAA Authorization form found on our website.

3) Complete Waiver - complete and include the Alteration/Waiver of HIPAA Authorization form found on our website.

CONFIDENTIALITY, SECURITY, AND PRIVACY CONCERNS

Data security

How is electronic data secured and confidentiality maintained?

Other, specify .....

Hard copy data

How is hard copy data secured?

1) locked office

2) locked file cabinet

3) other, specify

Other, specify..

Privacy

How will the informed consent discussion and other patient interactions ensure privacy?

1) private room

2) drawn curtains

3) other, specify

Other, specify

SUBMISSION ATTACHMENTS (non-exhaustive list)

protocol

consent

lay summary

Investigator Assurances

HIPAA Authorization

Alteration/Waiver of HIPAA

Alteration/Waiver of Consent

Authorization Revocation

Supplemental materials

Drug Brochure

FDA correspondences

Device manuals

recruitment materials

Waiver of Documentation of Consent

Send me a copy of my responses