CRP 109 Lecture 6

Question 1

Freezing (“soft lock”)

Answer 1

 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

Question 2

Locking (“hard lock”)

Answer 2

 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

Question 3

Study Closeout

Answer 3

 Completion of source document verification and data review
 Queries resolved
 Medical coding
 Investigator signatures obtained
 Locking of fields/forms

Question 4

Interim Lock

Answer 4

 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

Question 5

“Rolling” lock

Answer 5

process during which access to the database is limited while Data Management personnel confirm the
suitability of the data for final analysis

Question 6

Database Closure

Answer 6

 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

Question 7

Final Database Release

Answer 7

 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

Question 8

Problem with
Unlocking/Relocking

Answer 8

 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

Question 9

REB File Closure and Data

Answer 9

 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

Question 10

Why Archive?

Answer 10

 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

Question 11

Archiving Studies with Paper-
Based CRFs

Answer 11

 Original signed, dated, and completed CRFs
 Original documentation of queries and CRF corrections

Question 12

Archiving Studies with eCRFs

Answer 12

 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)

Question 13

Archive Storage Location

Answer 13

 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

Question 14

Biospecimen

Answer 14

 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

Question 15

Biospecimen Quality and Impact

Answer 15

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

Question 16

4 levels of lab containment protocols

Answer 16

-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

Question 17

Containment

Answer 17

-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

Question 18

Shipping/Transporting

Answer 18

• 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

Question 19

Equipment
Calibration/Documentation

Answer 19

 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