Monitoring Report Check List

Title Comment

1) Master File Review

Agreements –
➢ CDA- Dateof CDA must be Before IEC Documents Submission
➢ CTA-Should be signed by both parties & Date should be Before
IEC DocumentsSubmission
➢ Insurance Policy -
➢ Budget –SignedCopy (Institute Head,CRO Authorized person)
➢ IU-Version,mentioned Study team , Signed & Date (must be
before IEC DocumentsSubmission same as Delegation Log )
Feasibility-

PI Feasibility – Cross check as per mentioned in feasibility form -

Recruitment status, PI-COI Name, Qualification, and Availability.

Site Feasibility- Cross check as per mentioned in feasibility form-

Storage ,Lab facility ,Delegated room ,Accessibility

Protocol –Signed Protocol with Site address and stamp, Version, All
previous versions present.Amended Version.

IB –Version, Amendment, Mentioned ADR.

FDA Licenses –Duration
GMP Certificate
IEC- Original Document, Submission Letter -date must be before
approval letter & should be Signed by PI & Received Signature or IEC
Sectary.

Query Resolution- IEC Query Letter (Signed Received by PI), Query

Reply letter with Attached Documents.

Approval letter-Date Must be after Query Reply Submission Letter

IEC Members list, Contact Log of IEC members, Amendment Document

date, AE and SAE Submission of Initial and Final Report.

Regulatory- CTRI, DCGI Letter

ICF- All languages log, Translation certificate, ICP, Narration. DOB,

Sign of PI on ICF, PI & IEC contact communication with stamp,
Inclusion & Exclusion criteria.

Lab- Lab Accreditation Certificate, NABL Certificate.

 2) Documents-

Logs-(All Logs Signed Verified & updated )

Sponsor Contact Log, CRO Contact Log, Site Contact Log,

Lab Contact Log - All Labs Contact No and Mail ID (like ECG, X-ray,
ABG, Lab investigations)

Temperature Log- Time and Duration of maintaining temperature log,

Backup

Duty Delegation Log (Start date of Duties and responsibilities with sign
of PI-Date should be before IEC Submission same as in IU),

Subject Enrollment Log, Screening Log, Subject Withdrawal Log,

Dropout log, Screen Failure Log

Visit schedule log- Date scheduled and attended, Missed visit reason (If
Applicable)

ICF signed verification Log- Check sign done by subject or not, Cross
check

Telephonic Log- AE and SAE happen or not, Dose, missed dose reason,
subject call record, subject communication record need to cake Narration
of Telephonic Withdraw Consent ,Visit wise Calling.

IP Dispensing Record Log/ IP accountability log - Please check the

dispensed IP Batch No. is same or not, MFG date and Expiry Date of IP.-
Check the Consumed Tablets and Return tablets are proper or not

Monitoring log, Site training log, Site visit log, IP & Non IP shipment
Log, Communication log, subject call record log ,

CRF- Site No., Version, Date, Amendment, Activity chart, Inclusion &
Exclusion criteria, , Check the Filling of CRF done by study delegated
person

Source- Subject Diary/App, Screening Number, Rd. No, Lab Reports,

Covid Positive negative certificate(If applicable)Prakruti Evaluation
Form, QOL, HOMA IR,PI sign on all visits, Cross Checking with source
document& Lab investigation report, PI sign on all lab reports, Test
report form,

AE & SAE Reporting/Form- PI Sign, Date, Time With initial and final
report, Concomitant medication, AE and SAE log
Calibration Certificate of instruments used in study- Check working
properly or not, Check the all-calibration certificates are valid or not, all
instruments are available or not at site. Backup available

Travelling Allowance Charges Record

Monitoring Report-CAPA Report with sign of PI, Mail communication

with CAR.

MRC, CV, GCP Certificate-PI, Co-I, CRA& CRC.

ICF Taken Date, Lab Investigation Date, Randomization Date,

Washout period

Narration of AE & SAE- Source, CRF, Log, Form, ICP -Need to check
details of AE /SAE is Same in CRF, Log, AE Form, SAE Report ,ICP
and Call record narration.

Narration in ICP of-ICF, Dose missing, AE & SAE, drug dispensing

returning, deviation & violation

Protocol Deviation & Violation Log- Root Cause,Reported to

IEC/CRO/Sponsor, Date of Deviation /Violation happened to Capture
Date.