Longitude

Missing — resolve before sending to sponsor

Requirement	Status	Document evidence	Gap and citation
Investigator statement must include the IRB’s name and address	Missing	Section #5 states only: “Western Plains IRB (central IRB).”	No IRB street/mailing address is entered. 21 CFR 312.53(c)(1)(v).
Section #3 must identify every study site / research facility	Missing	Section #3 lists only “Harbourview General Hospital, Clinical Research Unit.” Attachment A says subjects attend dosing visits at “Harbourview’s Northside Satellite Clinic, 38 Birch Road,” and DEXA scans are performed and read at “Riverside Imaging Centre, 7 Mill Street.”	The Northside Satellite Clinic is plainly a site where protocol dosing and vital-sign procedures occur, and Riverside Imaging Centre performs a protocol-required efficacy assessment. Neither is listed in Section #3. 21 CFR 312.53(c)(1)(iii); FDA Frequently Asked Questions—Statement of Investigator (Form FDA 1572) (FDA 1572 FAQ), requirement to identify names and addresses of each study site in Section #3.
Section #6 must list subinvestigators assisting in the investigation; people directly performing protocol procedures and collecting/evaluating data should be listed	Missing	Attachment B: “M. Ortiz, research coordinator: recruits and consents subjects, collects and evaluates study data, completes the case report forms and keeps the study records. Not listed in Section #6 …”	M. Ortiz performs direct, substantive protocol and data responsibilities but is omitted from Section #6 solely because the site “lists physicians only.” That is not an appropriate basis for exclusion. 21 CFR 312.53(c)(1)(viii); FDA 1572 FAQ (individuals directly involved in protocol procedures and data collection; research coordinators generally should be listed in Section #6).
For a Phase 2 investigation, attach the required Phase 2/3 protocol outline—not the Phase 1 outline	Missing	Section #7 and Attachment A identify the study as “Phase 2.” Yet Section #8 marks the Phase 1 box: “[X] For Phase 1 investigations …”; the Phase 2/3 box is unchecked.	The wrong Section #8 category is selected for the stated study phase. 21 CFR 312.53(c)(3)(ii).
Phase 2/3 protocol outline must contain all required elements	Missing	Attachment A gives duration, maximum site enrollment, sites, and certain tests.	The outline does not state: (1) the approximate number of subjects to receive BW-117 versus placebo/other control; (2) subject characteristics by age and sex; or (3) copies or a description of the case report forms. A maximum total of 20 site subjects does not supply the treatment/control allocation. 21 CFR 312.53(c)(3)(ii).
Attach a CV or other statement of investigator qualifications	Missing	Both Section #2 checkboxes are blank. The site wrote: “Dr. Halvorsen’s CV is on file with Brightwater from a previous study, so it is not attached.”	The completed form/package does not include the required CV or other qualifications statement. The sponsor may have a prior CV in its records, but this submission does not establish that an appropriate, current qualifications document accompanies or supports this investigator’s participation in this protocol. 21 CFR 312.53(c)(2); FDA 1572 FAQ (Section #2 requires attachment of CV or other qualifications statement).
Financial-disclosure information and update commitment	Missing	No financial-disclosure form, information, or investigator commitment to promptly update financial interests appears in the 1572 or Attachments A–B.	The sponsor must obtain sufficient financial information and the investigator’s commitment to promptly update it during the investigation and for one year after completion. This can be collected outside the 1572, but it is absent from the provided completion package. 21 CFR 312.53(c)(4); 21 CFR Part 54.
Completed form must be signed and dated by the investigator	Missing	Section #10: “Signed: Robert A. Halvorsen, MD (wet ink signature).” Section #11: “(blank).”	The investigator date is absent. Do not treat the 1572 as completed until the investigator dates it. 21 CFR 312.53(c)(1); FDA 1572 FAQ (completed form must be signed and dated).
List all protocol names and code numbers in Section #7	Missing	Section #7 gives only the protocol title. The code “BWB-117-201” appears in the cover/header information, not in Section #7.	Section #7 should itself contain both the protocol name and the applicable protocol code number. 21 CFR 312.53(c)(1)(ii); FDA 1572 FAQ (list name and code number, if any, of all protocols under the IND conducted by the signing investigator).

Partly met — correct or clarify before sending

Requirement	Status	Document evidence	What remains / citation
Enter the investigator’s full legal name in Section #1	Partly met	Section #1: “Dr. Rob Halvorsen.” Signature: “Robert A. Halvorsen, MD.”	A name is entered, but “Rob” is inconsistent with the signed “Robert A.” and does not establish the investigator’s full legal name. Enter the full legal name in Section #1, with degrees/titles after it if desired. FDA 1572 FAQ (Section #1 should contain full legal name).
Enter locations where the investigation is conducted and, if different, where test article is shipped	Partly met	Section #3 provides the principal hospital location.	The form identifies a principal investigation location, but it omits the Northside Satellite Clinic and does not state whether investigational product will be shipped there, to the principal unit, or elsewhere. Confirm the actual ship-to location(s) and list them if different from the investigator’s address/location of record. FDA 1572 FAQ (Section #3 investigation and test-article shipping locations).
The signed form attests to accuracy of the CV/qualifications statement	Partly met	A wet-ink signature appears, but no date is entered and no CV/qualifications statement is attached.	A properly completed, dated 1572 can attest to the accuracy of the CV/qualifications document submitted with it. Here, the absent date and absent attachment prevent that conclusion. FDA 1572 FAQ (dated investigator signature attests to CV accuracy).
Conduct U.S. investigational-drug/biologic studies under IND requirements, including a signed 1572	Partly met	The listed facilities use a U.S.-style address; the investigator has signed, but Section #11 is blank.	The document supports an apparent U.S. site and shows a signature, but an undated form is not a completed signed-and-dated 1572. This form alone also cannot demonstrate compliance with all Part 312 requirements. 21 CFR 312.53(c); FDA 1572 FAQ (U.S. IND studies require a signed 1572).
Require 1572 signatures from U.S. and IND-included foreign-site investigators	Partly met	The U.S. investigator’s wet-ink signature is present.	The signature itself is present, but the investigator date is missing. No foreign IND site is identified in the provided materials. ; FDA 1572 FAQ.

Met

Requirement	Status	Document evidence	Citation
Name and address of investigator	Met, subject to the legal-name correction above	Section #1 identifies “Dr. Rob Halvorsen” and gives a complete Hospital/department mailing address.	21 CFR 312.53(c)(1)(i).
Titles, degrees, or qualifications may follow legal name	Met	The signature includes “MD.”	FDA 1572 FAQ.
Section #3 includes a medical school, hospital, or other research facility	Met in part for the principal facility	“Harbourview General Hospital, Clinical Research Unit, 1200 Quay Street …” is identified.	21 CFR 312.53(c)(1)(iii). The all-sites deficiency is listed above.
Name and address of clinical laboratory facilities used in the study	Met	Section #4 names “Meridale Central Laboratory Services, 45 Kiln Lane, Ashcombe, ST 00000.”	21 CFR 312.53(c)(1)(iv).
Only the primary laboratory need be listed when it can trace satellite/contract-lab samples	Met	Attachment A: Meridale sends bone-turnover samples to Ostell Analytics and “tracks every sample it sends there.”	FDA 1572 FAQ (primary laboratory may be listed where it can trace samples to satellite/contract laboratories).
Investigator commitments in Section #9: follow protocol and limit changes	Met	“The investigator’s commitments are printed on the form as issued and are unaltered.”	21 CFR 312.53(c)(1)(vi)(a).
Investigator commitment to comply with investigator obligations and other Part 312 requirements	Met	Same unaltered standard Section #9 representation.	21 CFR 312.53(c)(1)(vi)(b).
Investigator commitment to personally conduct or supervise the investigation	Met	Same.	21 CFR 312.53(c)(1)(vi)(c).

Not applicable or not determinable from this document

These are not treated as met, partly met, or missing because the trigger is absent or the matter cannot be established from a completed 1572 itself.

Requirement	Why it cannot be assessed from this document
Include alternative human-subject-protection mechanisms in a foreign-study IRB-waiver request	No foreign study, Part 56 waiver request, or waiver rationale is identified.
Attach an FDA waiver letter to the signed 1572, if a waiver is granted	No FDA waiver or waiver letter is identified.
Foreign-site 1572 obligations	No foreign site is identified in the document.

Things to confirm elsewhere — do not mark from this 1572

Sponsor selected Dr. Halvorsen based on appropriate training and experience: 21 CFR 312.53(a).
Sponsor ships investigational drug only to participating investigators: 21 CFR 312.53(b).
Sponsor selected a qualified monitor: 21 CFR 312.53(d).
Sponsor obtained the completed and signed-and-dated 1572 before permitting participation: 21 CFR 312.53(c).
Investigator received, read, and understood the protocol and investigator’s brochure before signing.
IRB review and approval occurred before initiation: 21 CFR 56.103(a).
Whether the central IRB arrangement satisfies all applicable Part 56 requirements.
Whether the investigator and all assistants actually comply with the commitments printed in Section #9.
Sponsor has obtained and retained complete, accurate financial-disclosure information and the required update commitment: 21 CFR 312.53(c)(4); 21 CFR Part 54.
Whether Brightwater’s previously held CV is current, corresponds to this investigator, and is adequate for this protocol; the form package should nevertheless be corrected to include/identify the qualifications document.
Test-article shipment destination(s), including whether the Northside Satellite Clinic will receive, store, dispense, or administer study drug.

Review a completed Form FDA 1572 before it goes to the sponsor

What it produced

Missing — resolve before sending to sponsor

Partly met — correct or clarify before sending

Met

Not applicable or not determinable from this document

Things to confirm elsewhere — do not mark from this 1572

What it draws on

Confirm these elsewhere

Sources

What it produced

Missing — resolve before sending to sponsor

Partly met — correct or clarify before sending

Met

Not applicable or not determinable from this document

Things to confirm elsewhere — do not mark from this 1572

What it draws on

21 CFR 312.53(c)From 21 CFR 312.53 — Selecting investigators and monitors

Confirm these elsewhere

21 CFR 312.53(a)From 21 CFR 312.53 — Selecting investigators and monitors

21 CFR 312.53(b)From 21 CFR 312.53 — Selecting investigators and monitors

Sources

List a qualified physician or dentist as a subinvestigator and make them responsible for medical decisionsFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Include alternative human-subject-protection mechanisms in foreign-study waiver requestsFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Attach the waiver letter to the signed 1572From Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Conduct U.S. investigational drug and biologics studies in compliance with IND requirementsFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Require 1572 signatures from investigators at U.S. and IND-included foreign sitesFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Prefer typed formsFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Sign and date the completed formFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Enter the investigator’s full legal nameFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Add titles, degrees, or qualifications after the legal name if desiredFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Enter the address where the investigator can be reachedFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Attach a CV or statement of qualificationsFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Use the investigator’s dated signature to attest to CV accuracyFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Enter investigation and test-article shipping locationsFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Identify every study siteFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

List only the primary laboratory when it can trace samplesFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

List individuals who perform protocol procedures and collect dataFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

List qualifying internists as subinvestigatorsFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Usually list research coordinators in Section 6From Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

List all protocol names and code numbersFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Identify phase 4 studies in Section 7From Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

21 CFR 312.53(d)From 21 CFR 312.53 — Selecting investigators and monitors

Use an alternative approach only if it satisfies applicable requirementsFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Contact FDA staff to discuss an alternative approachFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Call the appropriate number if you cannot identify FDA staffFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Submit unanswered questions to the listed email addressesFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

View FDA guidances as recommendations unless requirements are citedFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Complete the form as accurately as possibleFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Obtain a completed and signed 1572 before allowing participationFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Sign the form only after receiving sufficient informationFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Receive, read, and understand the protocol and investigator’s brochureFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Select only investigators qualified by training and experienceFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Collect the 1572 from the investigatorFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Complete and sign a new 1572 for a new protocol or investigatorFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Document other changes and inform the sponsorFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Obtain a signed investigator agreement for device studiesFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Meet all FDA IND requirements for foreign studies conducted under an INDFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Ensure foreign non-IND studies comply with 21 CFR 312.120 before submitting them to FDAFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Meet the listed criteria for an application based solely on foreign clinical dataFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Meet all FDA IND regulations for foreign studies conducted under an INDFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Operate sites as non-IND sites when local law prohibits signing a 1572From Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Conduct studies submitted to support marketing applications in compliance with 21 CFR 312.120From Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Comply with applicable laws and regulations in the study countryFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Obtain investigators’ written commitments to comply with local requirementsFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Sign Form FDA 1572 and conduct IND studies according to applicable regulationsFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Obtain IRB review and approval before initiating an IND studyFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

State an intention to use a GCP-compliant IEC in a waiver requestFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Submit the waiver request to the IND under which the study will be conductedFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Request an FDA waiver for conflicting requirementsFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Follow the protocol submitted to the INDFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Identify foreign sites and discuss data-pooling plansFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Promptly review investigational-drug safety informationFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Notify FDA and investigators of serious unexpected adverse experiencesFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Submit information from foreign clinical studies to FDAFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Identify foreign-study submissions in the cover letterFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Staple a two-page 1572 documentFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Have each co-investigator sign a separate 1572From Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Document home administration in study recordsFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Review off-site studies only when regulatory requirements are metFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Include rotational individuals and expected procedures in study recordsFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Select investigators qualified by training and experienceFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Ensure clinical-investigation assistants know and comply with their obligationsFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Submit financial disclosure information to the sponsorFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Submit a full protocol for postmarketing clinical trialsFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Provide a protocol or detailed description for phase 2 or 3 trialsFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)

Support phase 1 studies with an outlineFrom Frequently Asked Questions — Statement of Investigator (Form FDA 1572)