CRP 104 Leture 6 Flashcards
source documents
where information was first recorded or a certified copy of the original document. includes clinical findings, oberservations, or other activities necessary for reconstruction and evaluation of CT
Case Report Forms CRF
used to submit data for analysis. uses information from source documents. CRFs can be source documents
ensure standarsization of data collection. Signed/initialed and dated by person collecting data
investigator GDP responsibility
ensure accuracy, completeness, legibility, and timeliness of data reported to sponsor in CRFs and reports.
Investigator must approve changes to CRF with initials, signature, and date. or delegate this task to a qualified person
maintaining documents
investigator/institution retains documents and prevents premature or acciental destruction
document access
investigator/institution must provide docs at the request of monitor, auditor, REB, or regulatory body. Ensure changes to CRFs are documented properly and initialed by investigator or delegated personnel.
monitor GDP resonsibility
informing investigator of CRF entry error, omission or illegibility.
Audit trail definiton
documentation that allows reconstruction of course of events
confidentiality definition
prevention of disclosure to other than authroized individuals of a sponsor’s owned info or a subject’s identity
direct access definition
permission to access, analyze, verify, reproduce any records and reports important to evaluation of a CT. All individuals shoud take the precautions in compliance with regulatory requrements to ensure confidentiality of subject identities and sponsor’s proprietary information
documentation definiton
all records in any form that describe or records the methods, conduct and or results of CT, factors affecting trial and actions taken
what is GDP (6)
a process
-recording data
-review docs
-approval of docs
-issuance and disposal of docs
-ability to retrieve docs
-presnetation of docs
clarity
docs not open to misinterpretation by users. Designed to minimize errors (ie. instructions for format), and easy to check
regular review and update
docs kepy up to date with changes in regulations or processes. distributed in controlled manner to ensure only most recent versions are available. must be accessible to those who need them.
formal presentaions
documents prepared in accordance with a written procedure.
electronic records (7)
-validation, testing systems to provide evidence that system does what is expected, operational checks (levels of security), protection of records for duration of retention period (25 yrs), proedures for using electronic system, limited used by authorized personnel, audit trail, production quality.
Canada electronic records
both electronic and manual systems must be run together for a period before changing to exclusively electronic system
FDA electronic documents
specific requirements for signature components and manifests
ALCOA-C
attributable, legible, contemporaneous, original, accurate and complete
SOP defintion
detailed, written instructions to achieve uniformity of performance of specific function
archiving SOP
archived with dates active so inspector can verify if there were deviations. all authors identified
training on SOPs
all training on SOPs and amendments must be documented and kept in the ISB
protocol v. CRF. v. source
protocol: defines data needed for CT
CRF: data set to evaluate CT
Source: original data and meta data
CRF
designed by sponsor or CRO, standardized collection of protocol data
-limites to defined fields, cannot write just anything
source documents
designed by research sites using CRFs from sponsor. Readily identify data for CRF entry, i.e. underline medical terms. includes meta data (data supporting the data)
source docs considerations for consistency and quality (8)
-data definitions
-consistent design
-sequence of data logical
-one set of authentification
-decision trees
-sufficient space
-page numbers
-streamlines supporting links, calibration records
-identify historical errors and eliminate them
