Challenge: ICH GCP Data Handling and Management
Question Number 1

According to ICH GCP when using electronic trial data handling and/or remote electronic trial data systems, the sponsor should ensure that the systems are designed to permit data changes in such a way that the data changes are documented and that there is no deletion of entered data. This means keeping which of the following trails

  1. audit trail
  2. data trail
  3. edit trail
A
1 only
B
1 and 2 only
C
1 and 3 only
D
All of them

PharmaSchool Logins

Learning Management Centre
CPMC Login
My GCP Zone Login
Retrieve Online Order

 

PharmaSchool Online Courses:
Click here for the full range of Online GCP, Clinical Research and Development Courses from PharmaSchool.
Users in the following countries:
ALBANIA ANDORRA ANGOLA ARGENTINA ARMENIA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BARBADOS BELARUS BELGIUM BELIZE BENIN BERMUDA BHUTAN BOSNIA AND HERZEGOVINA BOTSWANA BRAZIL BRUNEI DARUSSALAM BULGARIA BURKINA FASO BURUNDI CAMEROON CANADA CHILE CHINA COLOMBIA CROATIA CZECH REPUBLIC DENMARK DOMINICAN REPUBLIC ECUADOR EGYPT ETHIOPIA FINLAND FRANCE GAMBIA GEORGIA GERMANY GHANA GREECE HAITI HONDURAS HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN, ISLAMIC REPUBLIC OF IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KUWAIT LEBANON LITHUANIA LUXEMBOURG MACEDONIA, THE FORMER YUGOSLAV REPUBLIC OF MALAWI MALAYSIA MALI MEXICO MOLDOVA, REPUBLIC OF NEPAL NETHERLANDS NEW ZEALAND NIGERIA NORWAY PAKISTAN PANAMA PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR ROMANIA RUSSIAN FEDERATION RWANDA SAO TOME AND PRINCIPE SAUDI ARABIA SENEGAL SERBIA SINGAPORE SLOVAKIA SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SUDAN SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TURKEY UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UNITED STATES UZBEKISTAN VANUATU VIET NAM ZAMBIA ZIMBABWE
 
 
Courses
News & Corporate Information