Data Management

Question 1

GIGO

Answer 1

Garbage In, Garbage Out: data quality can be made better with coding, but bad data cannot be saved.

Question 2

ICD

Answer 2

International Classification of Diseases

WHO. Standard Diagnosis Terminology

Question 3

WHO ATC

Answer 3

WHO Anatomical, Therapeutic, Chemical

codiert nur die Wirkstoffe (Medikamententerminologie)

Question 4

WHO Drug / WHO DD(E)

Answer 4

Codes the drug name (ie: Aspirin Ratiopharm)

Question 5

MedDRA

Answer 5

Medical Dictionary for Regulatory Activities

Entwicklung und Pflege durch MSSO (Maintenance & Support Services Organisation)

Codiert Medizinische, gesundheitsbezogene und regulatorische konzepte für ALLE phasen der Entwicklung von arzneimitteln für den einsatz bei Menschen

Codes for events (Ereignissen) and not outcomes (ie: death)

Question 6

MSSO

Answer 6

Maintenance & Support Services Organisation

Develops and administers MedDRA

Question 7

MedDRA: SOCs

Answer 7

System Organ Classes

Question 8

MedDRA: PTs

Answer 8

Preferred Terms (2nd most specific)

Beschreiben ein einzelnes, abgrenzbares medizinisches Konzept (symptom, diagnosis, untersuchungsergebnis)

Question 9

MedDRA: LLTs

Answer 9

Lowest Level Terms

Question 10

SmPC

Answer 10

Summary of Product Characteristics (label)

Question 11

RMP

Answer 11

Risk Management Plan

Question 12

JMO

Answer 12

MedDRA nicht von MSSO in Japan abgedeckt. JMO administers Japanese Version.

Question 13

Wie oft wird MedDRA weiterentwickelt (Updated?)

Answer 13

2 mal jährlich

Question 14

CTCAE

Answer 14

Common Terminology Criteria for Adverse Events

developed by National Cancer Institute, mostly used in oncology studies to describe Klassifikation und Bericht von AEs, Schweregradeinteilungen die von MedDRA nicht abgedeckt werden.

Question 15

CTC

Answer 15

Common Toxicity Criteria

Klassifikation und Bericht von Chemotherapie-assoziierten Adverse Events bie Krebspatienten

Question 16

What should be done to increase the progress-curve of a study?

Answer 16

1. relax ein/ausschluss kriterien
2. increase enrollment, more marketing
3. open more study centers

Question 17

Who is present at Blind Data Review meeting?

Answer 17

Project Leader (Project status)
Mediziner (SAEs, Coding)
Clinical Lead & CRA (protocol deviations)
DM Lead, DBP, CDA
Statistiker (Mock-Tables, protocol violations)

Question 18

ITT

Answer 18

Intent to Treat population (analysis)

In an ITT population, none of the patients are excluded and the patients are analyzed according to the randomization scheme. In other words, for the purposes of ITT analysis, everyone who is randomized in the trial is considered to be part of the trial regardless of whether he or she is dosed or completes the trial.
For example, if people who have a more refractory or serious problem tend to drop out of a study at a higher rate, even a completely ineffective treatment may appear to be providing benefits if one merely compares the condition before and after the treatment for only those who finish the study (ignoring those who were enrolled originally, but have since been excluded or dropped out).

Medical investigators often have difficulties in completing ITT analysis because of clinical trial issues like missing data or poor treatment protocol adherence.

Question 19

PPP

Answer 19

Per Protocol Population

This analysis can only be restricted to the participants who fulfill the protocol in the terms of the eligibility, interventions, and outcome assessment. This analysis is known as an “on-treatment” or “per protocol” analysis. Also, the per-protocol restricts the comparison of the treatments to the ideal patients, that is, those who adhered perfectly to the clinical trial instructions as stipulated in the protocol. This population is classically called the per-protocol population and the analysis is called the per-protocol-analysis. A per-protocol analysis envisages determining the biological effect of the new drug. However, by restricting the analysis to a selected patient population, it does not show the practical value of the new drug.

Question 20

Major protocol deviations

Answer 20

• ICF not signed
• Patients do not satisfy the inclusion and/or exclusion criteria,
• Patient drop outs
• A patient is randomized to Treatment A, but is treated with Treatment B,
• Some patients are not compliant, that is, do not take their medication as instructed, and so on.

Question 21

Database Lock

Answer 21

Das Schließen einer Datenbank, nachdem alle Daten validiert wurden (Diskrepanzen addressiert und gelöst), sodass keine weiteren Änderungen vorgenommen werden können.

1. Alle Patienten frozen und locked.
2. Ein “Case Report Form summary” Report generated to confirm lock of all patients

Question 22

GCP for Data Management

Answer 22

1. Quality control processes
2. SOPs
3. Dokumentation und Ablage
4. Audit trails
5. Training
6. Validation
7. Datenschutz
8. Safeguard Blinding
9. RTSM (Randomization & Trial Supply Management): maintain randomization codes and procedures for breaking codes

Question 23

Computer System Validation

Answer 23

dokumentierten Prozess, mit dem konsistent und reproduzierbar sichergestellt wird, dass ein Computer-System genau das tut, wofür es entwickelt wurde.

V-Modell

• Zweck des systems vollständig, korrekt und effizient erfüllt wird.
• Maßnahmen unternommen, das System in einem validierten Zustand zu halten.

Question 24

21 CFR Part 11

Answer 24

FDA kriterien für:

• elektronische Daten und Signaturen als vertrauenswürdig, zuverlässig und gleichgestellt zu paper-docs.
• bekräftigt die Anforderungen von GCP

Question 25

Clinical Data Manager, CDA tasks

Answer 25

1. creating setup specifications for: - CRF - Data Validation Plan 2. In-house data review - Cleaning / QUery management - reconciliation of SAEs - medical coding

Question 26

Clinical Database Manager

Answer 26

- Database build - CRF umsetzen in DB system - validation programming - set-up acceptance testing environment - Listings erstellen

Question 27

Gemeinsame Tasks | Clinical DM and Clinical Database Manager

Answer 27

- (computer system) validation - Quality management (documentation) - communication, soft skills, english

Question 28

ADaM

Answer 28

standard for data analysis (FDA)

Question 29

CDASH Library

Answer 29

Clinical Data Acquisition Standards Harmonization - defines standards for collection of data

Question 30

SDTM

Answer 30

Standard for clinical trial data submission (ie: EMA, FDA)

Question 31

CTCAE

Answer 31

Common Terminology Criteria for Adverse Events - National Cancer Institute - used in oncology studies - enthält schwergradeinteilungen die nicht von MedDRA abgedeckt werden.