Inspection Readiness Visits (IRV)

Why is IRV needed since readiness shall be ensured from the beginning of the study?

  1. Gives the sponsor/CRO and site staff required confidence to face the inspection awareness about status of study documents at the study site.
  2. Study details and processes followed are refreshed in the mind of PI and study staff.
  3. Site staff is trained in handling the inspection which gives confidence to the site team.

IRV is also important considering the change in the site staff, change in site infrastructure and time elapsed from study conduct.

Ideal time for conducting IRV?

  1. After completion of recruitment and before close out
  2. As part of close out visits

Note: all the data that would be reviewed by regulatory agency should be available at the time of IRV to ensure comprehensive review.


Who should be part of IRV?

  1. Representative from clinical operations of sponsor/CRO
  2. Study monitor
  3. QA

Which sites to be targeted for IRV?

  1. High number of Randomization and/or withdrawals
  2. Regulatory inspections in the past/no past inspections/observations in past inspections/duration from last inspection
  3. Number of Protocol deviations/Major PDs
  4. Number of rescreening
  5. SAEs/pregnancy reported
  6. Sites with any data issues identified during the study
  7. Sites with outlier data

Sites which fall under multiple categories listed above should be given high priority for IRV.


Actions during the Inspection Readiness visit?

  1. Check for obvious trends/gaps in data and identify potential questions
  2. Discuss site’s explanation for potential questions/gaps and implement CAPA for critical/major issues, if needed
  3. Conduct sessions on inspection readiness and refresher session on key study processes and protocol for site staff.
  4. Ensure:
    • a. Closure/FU on AE/SAEs/Pregnancies
    • b. Availability of all study documents and their proper filing
    • c. Reporting of all Protocol Deviations, CSR, study progress to IRB
    • d. Availability of metadata/supporting data such as hospital OPD/IPD
    • records/MRD files
    • e. ISF is updated and signatures of PI on all the logs.
    • f. Readiness of all stakeholders such as local lab, imaging centers or any
    • other vendors used in the study.
    • g. Availability of copies of all electronic data such as e-CRF, IWRS, e-PRO, e-
    • COA (as applicable) along with audit trail and ensure that site is able to
    • readily access the data
    • h. Closure of all actions for monitoring and audit
  5. Check Corrective actions implemented for previous inspection observations
  6. Check availability of retention samples and their storage conditions monitoring throughout retention period for BA/BE trial
  7. Ensure Equipment/instrument calibration for the entire duration of the study.

Detailed inspection readiness visits with proper planning and considering the above aspects can give confidence to site, CRO and sponsor in facing the inspection successfully.


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