CRP 104 Leture 6

Question 1

source documents

Answer 1

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

Question 2

Case Report Forms CRF

Answer 2

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

Question 3

investigator GDP responsibility

Answer 3

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

Question 4

maintaining documents

Answer 4

investigator/institution retains documents and prevents premature or acciental destruction

Question 5

document access

Answer 5

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.

Question 6

monitor GDP resonsibility

Answer 6

informing investigator of CRF entry error, omission or illegibility.

Question 7

Audit trail definiton

Answer 7

documentation that allows reconstruction of course of events

Question 8

confidentiality definition

Answer 8

prevention of disclosure to other than authroized individuals of a sponsor’s owned info or a subject’s identity

Question 9

direct access definition

Answer 9

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

Question 10

documentation definiton

Answer 10

all records in any form that describe or records the methods, conduct and or results of CT, factors affecting trial and actions taken

Question 11

what is GDP (6)

Answer 11

a process
-recording data
-review docs
-approval of docs
-issuance and disposal of docs
-ability to retrieve docs
-presnetation of docs

Question 12

clarity

Answer 12

docs not open to misinterpretation by users. Designed to minimize errors (ie. instructions for format), and easy to check

Question 13

regular review and update

Answer 13

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.

Question 14

formal presentaions

Answer 14

documents prepared in accordance with a written procedure.

Question 15

electronic records (7)

Answer 15

-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.

Question 16

Canada electronic records

Answer 16

both electronic and manual systems must be run together for a period before changing to exclusively electronic system

Question 17

FDA electronic documents

Answer 17

specific requirements for signature components and manifests

Question 18

ALCOA-C

Answer 18

attributable, legible, contemporaneous, original, accurate and complete

Question 19

SOP defintion

Answer 19

detailed, written instructions to achieve uniformity of performance of specific function

Question 20

archiving SOP

Answer 20

archived with dates active so inspector can verify if there were deviations. all authors identified

Question 21

training on SOPs

Answer 21

all training on SOPs and amendments must be documented and kept in the ISB

Question 22

protocol v. CRF. v. source

Answer 22

protocol: defines data needed for CT
CRF: data set to evaluate CT
Source: original data and meta data

Question 23

CRF

Answer 23

designed by sponsor or CRO, standardized collection of protocol data
-limites to defined fields, cannot write just anything

Question 24

source documents

Answer 24

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)

Question 25

source docs considerations for consistency and quality (8)

Answer 25

-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