CRP 109 Lecture 6 Flashcards
Freezing (“soft lock”)
A Monitor can freeze data to prevent any modifications by the site
Can be applied to all fields and forms of a patient’s data
Prevents future data entry or edits but allows source document
verification
Can repeatedly be established and removed by the Monitor only
-sites are still able to
respond to queries
Locking (“hard lock”)
Locking is performed by the Data Manager
Can be applied to all fields and forms of a patient’s data
Can repeatedly be established and removed by the Data Manager
only; cannot be removed by the monitor
Prevents all users from modifying the data point in any way
Study Closeout
Completion of source document verification and data review
Queries resolved
Medical coding
Investigator signatures obtained
Locking of fields/forms
Interim Lock
Process used to take a “snapshot” of a database at a particular
point in time while the study is still in progress
Facilitates statistical analyses, listings, and report generation
Can take place as many times as needed during a study
Database often has unresolved queries although some data
cleaning efforts will be made in advance
“Rolling” lock
process during which access to the database is limited while Data Management personnel confirm the
suitability of the data for final analysis
Database Closure
Final step in data cleanup and finalization
Final data lock must be completed and documented prior to
database closure
All documentation for database closure should be updated
and archived according to SOPs and the Data Management
Plan
Every study should make use of a Database Closure Checklist
Final Database Release
After a database has been closed with appropriately signed
authorizations and documentation, the release of data (to PI,
sponsor, manuscript writer, etc.) may occur
If a study is blinded, release of the database is typically necessary
prior to un-blinding of the data
Problem with
Unlocking/Relocking
Questions that will arise regarding data integrity and other
associated statistical concerns
Too much variability with the way that study teams document the
locking/unlocking process
Low confidence that this is always documented thoroughly and done
correctly
REB File Closure and Data
No longer permitted to collect new data once a study’s REB file
is closed at a site but you can use the existing data that was
collected prior to REB file closure
Limited to query resolution and data corrections only using
existing data only
Why Archive?
To meet ICH GCP requirements
To ensure that the sponsor is able to answer questions related to
clinical research data that may emerge many years after study
closure
To comply with 21 CFR Part 11 requirements for clinical records that
are part of an electronic submission
To comply with FDA and Health Canada guidelines for data
archiving
Archiving Studies with Paper-
Based CRFs
Original signed, dated, and completed CRFs
Original documentation of queries and CRF corrections
Archiving Studies with eCRFs
Documentation of type of
hardware/software used to capture the
data
Reports describing the data and
validation of study metadata, including
data structures, edit check descriptions,
and electronic data-loading specifications
Study’s Data Management Plan
Audit trail
PDF or Excel file of the de-identified
participant data (downloaded from the
eCRF system)
Archive Storage Location
Investigator site
Offsite record storage company
e.g. Iron Mountain
Two security measures – storage area level & storage container level
Storage conditions
minimise risk of damage or loss of information
Biospecimen
Samples of material, such as urine, blood, tissue, cells, DNA,
RNA, and protein from humans, animals, or plants
Stored in a biorepository and used for laboratory research
If the samples are from participants, medical information may
also be stored along with a written consent to use the samples in
laboratory studies
e.g. Informed Consent Form for Biobanking / Future
Biomedical Research
Biospecimen Quality and Impact
Research Implications:
* Irreproducible results leading to confusion and lost data from valuable participant
samples
* Misinterpretation of artifacts as biomarkers
Clinical Implications:
* Potential for incorrect diagnosis
* Potential for incorrect treatment
* Impact on hospital stays, costs and patient outcomes
4 levels of lab containment protocols
-Containment Level 1 labs – work with the least dangerous
agents, require fewest precautions
Containment Level 4 labs – strictest methods because they are
dealing with agents that are the most dangerous to human health
Containment
-safe methods, facilities and equipment for managing infectious materials in the laboratory environment where
they are being handled or maintained
-reduce/eliminate exposure of laboratory workers, other persons, and the outside environment to potentially
hazardous agents
Shipping/Transporting
- IATA Transportation of Dangerous Goods (TDG) certification
required every 2 years - IATA Dangerous Goods Regulations is a trusted source to
help you prepare and document dangerous shipments
Equipment
Calibration/Documentation
Medical Engineering (or equivalent) is responsible for equipment
tagging and supporting equipment:
Inspection, installation, monitoring, preventative maintenance, repairs, etc
Maintenance and calibration records are maintained by the department
responsible for care and maintenance of the equipment
Available for distribution in the event of an audit
