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 [Link] 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.
