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I
CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING
III. STANDARDS FOR EXPEDITED REPORTING
B. Reporting Time Frames
1.… +
E
COMMISSION IMPLEMENTING DECISION (EU) 2022/729
of 11 May 2022 – amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for qua… +
COMMISSION IMPLEMENTING DECISION (EU) 2022/729
of 11 May 2022 – amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for qua… +
G
CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO AN INCAPACITATED ADULT
Conditions
1. The subject’s legal representative has had an interview wit… +
CONDITIONS AND PRINCIPLES WHICH APPLY IN RELATION TO A MINOR
Conditions
1. Subject to paragraph 6, a person with parental responsibility for the mino… +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 12. +
CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS
Principles based on International Conference on Harmonisation GCP Guideline
[...]
12. In… +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 6. +
CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS
Principles based on International Conference on Harmonisation GCP Guideline
[...]
6. A t… +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 10. +
CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS
Principles based on International Conference on Harmonisation GCP Guideline
[...]
10. Al… +
CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS
Principles based on International Conference on Harmonisation GCP Guideline… +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 7 +
CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS
Principles based on International Conference on Harmonisation GCP Guideline
7. The medi… +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 16. +
CONDITIONS AND PRINCIPLES WHICH APPLY TO ALL CLINICAL TRIALS
[…]
16. Provision has been made for insurance or indemnity to cover the liability of the… +
CONDITIONS FOR SENSITIVE PROCESSING UNDER PART 4
Consent to particular processing
1 The data subject has given consent to the processing.Medical purpo… +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 3-001 +
CONDITIONS WHICH APPLY IN RELATION TO AN ADULT ABLE TO CONSENT OR WHO HAS GIVEN CONSENT PRIOR TO THE ONSET OF INCAPACITY
1. The subject has had an in… +
I
Case Report Form (CRF)
A tool designed to record protocol-required information to be reported by the investigator to the sponsor on each trial partic… +
Case report forms (CRFs)
[…]… +
Certified Copy
A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by genera… +
U
USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 GLOSSARY OF TERMS +
Certified Copy: A copy (paper or electronic) of original information that has been verified, as indicated by a dated signature, as an exact copy, havi… +
G
Classification
1. Devices shall be divided into Classes I, IIa, IIb and III. Classification shall be carried out in accordance with Annex IX.
2. In th… +
E
Classification of devices
1. Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and… +
Classification of devices
1. Devices shall be divided into classes A, B, C and D, taking into account the intended purpose of the devices and their… +
