The monitoring process . Stages of a monitoring visit. Before the visit During the visit After the visit. During the visit. The monitor will assess or discuss: Site, staffing, research labs or other facilities Regulatory file and study records
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all information in original records and certified copies of original records of clinical findings, observations or other activities in a clinical trial necessary for the reconstruction an evaluation of the trial. (ICH GCP1.51)
original documents, data and records(e.g. hospital records, lab notes, clinical charts, subjects diaries, pharmacy dispensing records, x-rays, subject files etc) (ICH GCP 1.52)
SDV: evaluation of the conformity of the data presented in CRFs with source data.
Main aim: confirm that the data collected is complete, accurate, reliable and verifiable so as to give confidence to sponsor and regulatory authorities in the data being used to support a marketing application.
Without SDV, no scientist can have confidence in data presented and conclusions derived.
SDV process (cont)
Key data :
10 efficacy data
Physical exam/vital signs
Record that patient entered clinical study and date of IC
Any gross errors in these might be detrimental to the scientific and ethical quality of the clinical trial.
Methods of SDV:
Back to back
Direct method- monitor has direct access to source data (ICH GCP E6 1.21,5.15)
Extent of SDV ???
Depends on: clinical trial phase, quantity of data, time availability, man power availability, investigator research experience, company policy,
SDV process (cont)
Critical data: focal to aims and objectives of study and must be correct.
Informed consent to participate
Conformance to inclusion/exclusion criteria
Primary efficacy endpoints
Secondary efficacy endpoints
Recording and reporting of SAEs
Documentation that that study drug was prescribed and at the specified dosage
Visit dates as per protocol
Non-critical data e.g. very neat, high numbers of overwriting, rapid recruitment, lack of SAEs when they would be expected etc.
CRF content review:
Missing, incomplete or illegible entries, signatures or dates
Data recorded in wrong fields
Illogical, inconsistent or ambiguous data
Entries demonstrating failure to follow protocol
Inadequate documentation of corrections
Data entered directly to CRF
Brief medical history/ scanty clinical notes
Several volumes of SD
Maximum acceptable error rate
Document the SDV process
CRFs checked and why they were selected
Critical and non-critical data items checked
Nature and frequency of errors
Any corrective actions undertaken
Informed consent documents
What to check:
Each participant has personally signed and dated ICD prior to study procedures.
Appropriate use of independent witness
Correct version being used
Names of subjects/person giving consent, date and time