Site Visit Interim Report

Site Visit Interim | Visit Date: 27Apr2022 | Protocol #: RPC01-3333 | Investigator: Gordon, Jim - Date Printed 27Apr2022

Site Visit Interim Report

Visit Dates27Apr2022

Last Visit20Dec2021- Site Visit Interim

Monitor Tanya Narayanan

InvestigatorSite No. 120Jim GordonSite AddressGreenfield Clinical Research 2000 N. Old Hickory TrailMiami, Florida, 33101United States

Project SitePhone: 9018200090PI email: [email protected]

SponsorRockGen Inc. Protocol #: RPC01-3333Protocol Indication: Ulcerative colitis

GEN04 Were other location(s) visited? N/A

IQVIA AttendeesTanya Narayanan, Primary CRA Site AttendeesJim Gordon, Principal Investigator; Maria Zarkova, Study Coordinator, Primary Sponsor AttendeesNoneNote: If a related Action item appears in the visit report an indicator 'A' (Action Item) will be displayed alongside the question.

Subject EnrollmentTotal Number of subjects screened to date

Total Number of subjects screen failed to date

Total Number of subjects randomized todate

Total Number of subjects discontinued to date

Total Number of Subjects Completed study to date

3 0 3 3 0Comments

None None None At the end of 10 weeks of induction phase, both subjects 11791001 and 11791002 were deemed to be non-responders and hencerolled over into the Open Label Extension (OLE) study - RPC01-3102.

Subject 11791003 missed Week 5 visit scheduled for 15-Nov- 2016. Subject continued taking IP and returned empty bottles and DiaryPRO on 22-Nov-2021. Subject withdrew consent and decided not to cooperate with site for early term procedures.

None

Ability to Enroll Subjects ENR25 Is the site on target with recruitment and demonstrate the Yes

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*This document is for training purposes only. Names, dates, and locations are fictional.


capability to continue recruiting subjects as per contracted/ previously agreed numbers?

Comments Primary SC Ms. Zarkova informed CRA that there is one patient that the site is actively following-up to screen for this study. Ms. Zarkova informed that they will try to screen this subject during mid-May.

ENR27 What action has site taken to meet recruitment target? N/A

Comments SC Ms. Zarkova confirmed that there will be no change in recruitment numbers or strategy.

ENR28 What additional actions will site undertake to meet recruitment target? N/A

Comments NONE

ENR29 Does site need additional support to be successful in recruitment? No

Comments NONE

ENR30 Has the PI changed contracted/ previously agreed numbers of screened/ randomized subjects? No

Comments NONE

Status of Clinical Study Documents

CSD01 Have there been any changes to clinical study documents (Protocol, ICF, IB, etc) since the previous monitoring visit? No

Comments NONE

Verification of ICF (Subject Informed Consent Forms)

ICF04Did the monitor confirm that the current version of the written informed consent was obtained for each new subject prior to study participation?

N/A

Comments There has been no recruitment at this site since last monitoring visit.

Current ICF Version = 4.0 Version Date: 12-Aug-2022 Cohort 1

ICF05 Were all subjects appropriately re-consented with the current version of the ICF? N/A

Comments NONEICF06 Does the ICF log need to be updated? N/A

Comments NONE

Source Data Monitoring

PD01 Were all enrolled/randomized subjects eligible per protocol criteria? N/A

Comments There has been no recruitment at this site since last monitoring visit.

SDV04 Are all original source documents on site and available for reviewand monitor can infer unique existence of each subject? Yes

Comments IRT, ERT and EDC was reconciled with respect to subject status.

CRF01 Have all relevant Case Report Form (CRF) pages been completed? Yes

Comments NONE

SDM01 Were relevant data elements and CRF pages monitored as described in the clinical operations plan? All Pages Onsite

Comments NONE

CRF02 Have all relevant CRF pages been retrieved/submitted as required? Yes

Comments NONECRF03 Were all outstanding data clarification forms/queries resolved? Yes

Comments NONE

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PD02 Were protocol deviations identified? No A

Comments NONE

SAE20 Have there been any new SAEs / UADEs/SADRs or changes to previously reported events since last visit? No

Comments NONESAE18 Were all SAEs reported to the IRB/EC appropriately? N/A

Comments NONESAE19 Do all SAEs have the required source documentation? N/A

Comments NONE

IP Control and Supplies IP01 Does the study require the use of IP? Yes

Comments NONE

IP10 Are all IP and related supplies on site appropriate for dispensing and stored within protocol requirements? Yes

Comments CRA verified the temperature logs and no temperature excursions were identified.

CRA also verified the frozen sample shipment log and found that they were up-to-date.OMM17 Was IP accountability performed? Yes

Comments NONE

IP11 Are all investigational product accountability records current, complete, and accurate? Yes

Comments CRA confirmed that site has acknowledged IP receipt with Clinical Supply in Endpoint IRT.

IP20 Did all study staff remain blinded/unblinded as per protocol requirements? Yes

Comments NONE

Facilities and Equipment

OTH31 Have all facilities remained within protocol requirements since the last visit? Yes

Comments NONE

OTH36 Are biological samples being handled and documentation available per protocol requirements? Yes

Comments Primary PK samples are sent on a daily basis on dry ice.

Back-up samples are also sent within a month of the date the primary samples were collected on dry ice.OTH33 Does the site have sufficient laboratory supplies? Yes

Comments CRA confirmed availability of adequate non-expired lab kits at site.

OTH37Have there been any changes to electronic systems, including user requirements or user access since last visit that would impact Part 11 compliance?

No

Comments Site uses both paper and electronic medical records as source documents. CRA access to the electronic medical records is provided by printed hardcopies that are duly certified by PI or delegated site staff.

OTH35 Are the local clinical laboratory facilities meeting protocol requirements for the study? N/A

Comments Site uses central lab for all lab testing procedures.

CRA reviewed frozen sample shipment log and found it to be up-to-date.OTH34 Are there any changes to the satellite sites, including new sites? N/A

Comments NONE

Staff Training/PI Oversight PIC15 Is the PI adhering to the study requirements? Yes

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Comments NONEPIC13 Have there been any changes to study staff? No A

Comments NONE

PIC17 Does the PI have appropriate oversight of responsibilities delegated to study staff? Yes

Comments NONE

PIC19 Has the PI properly documented his/her delegation of study responsibilities? Yes

Comments NONEPIC20 Is all required study staff training documented? Yes

Comments CRA confirmed that the site training log is current.

Adequacy of ISF OMM18 Was the ISF reviewed? (If yes, please attach the ISF checklist) Yes

Comments CRA also reviewed the SRM and confirmed that all current checklists / guidance documents have been filed in the SRM.ISF05 Were all essential documents current and filed appropriately? No A

Comments The 1572 needs to be updated with the new address for QQQSolutions (Central Lab) in Valencia, CA.

ISF10 Did the PI receive, review and file all Safety Letters appropriately? Yes

Comments CRA confirmed that

(i) All safety letters issued from 20-Dec-2021 till 25-Apr-2022 have been filed in the safety binder appropriately.

(ii) PI Dr. Gordon has acknowledged all safety letters in a timely manner.

ISF11 Have all Safety Letters been reported according to local requirements? N/A

Comments Site uses central IRB and hence all reportable Safety Letters are automatically filed by IQVIA pharmacovigilance to the central IRB.

Authors Comments MON05 General comments? If yes, specify in Question Comments Yes

Comments This visit in triggered by number of eCRF pages requiring SDV and is in accordance with monitoring frequency guidelines in COP.MON06 How were the findings Discussed with the PI? In Person

Comments NONE

Source Data Monitoring LogSDM02 Subject # SDM03 Visits Reviewed11791001 AE, Concomitant Medications, Drug Interruption / Overdose 11791002 AE, Concomitant Medications, Drug Interruption / Overdose 11791003 Screening - PFT, OCT, End of Study

Additional CommentsNoneAction Item Log

Open Action Items

Ref#

ISF05

Title Were all essential documents current and filed appropriately? Author Tanya NarayananOpen Date

25Apr2022 Due Date 31Jul2022

Action Required

Primary SC Ms. Zarkova will need to update FDA 1572 with the new address for QQQSolutions (Central Lab) in Valencia, CA. CRA will verify if this has been completed and a copy has been provided to IQVIA for internal filing.

Action Item Notes

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Resolved Action Items Ref#

PD02

Title Were protocol deviations identified? Author Tanya Narayanan

Open Date

09Feb2022 Due Date 29Apr2022 Resolution Date 25Apr2022

Action Required

PI to review, sign and date the PD log for SMV dated 9 Feb'21

Resolution

CRA confirmed that the PD log was reviewed and acknowledged by PI Dr. Gordon.

Action Item Notes

Note 1 Created 17May2021Creator

Note 2

PI to review, sign and date the PD log during next onsite monitoring visit.

The PD log was updated with the new finding on 20-Dec-2021. PI to review and sign this updated PD log during next monitoring visit.

CreatedTanya Narayanan 26Dec2021

Creator Tanya Narayanan

Ref#

PIC13

Title Have there been any changes to study staff? Author Tanya Narayanan

Open Date

20Dec2021 Due Date 31Mar2022 Resolution Date 25Apr2022

Action Required

The stop date for Sub-I Dr. Rolando Leal who left the study team needs to be updated on the delegation log. CRA to confirm if this has been done during next monitoring visit.

Resolution

CRA confirmed that the stop date for Dr. Leal has been updated on the site delegation log.

Action Item Notes

Attachments

Attachment NameSite 120_Gordon_25Apr2022_ISF Checklist

ESignature

Submitted By Electronic Signature: Date / Time signed: Original Date of Submission

Tanya Narayanan 26Apr2022 04:10:53 PM GMT 26Apr2022 12:12:25 AM GMT

Reviewed/Approved By Electronic Signature: Date / Time signed:

Afroze Calcuttawalla 27Apr2022 09:26:26 AM GMT

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Site Visit Interim Report

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