Flutemetamol For Alzheimer's - Phase 3 Results Released
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Hello Friends....
Lets Join a New group... We Are CR Professionals...
We Are CR Professionals.... is group which will cover every aspect of Clinical Research.
It Will cover Any Clinical Research job vacancy ( govt. / Private) , all the Clinical Reasearch Stuff( Photos , videos, research Articles, notes , discussions etc....)
Regards
Dr. Gaurav Arora
http://www.facebook.com/
Questions asked in CRC & CRA Interviews
Define the following:
1. GCP
2. Clinical Research
3. Clinical Trial
4. Inform Consent Document
5. Inform Consent Process/LAR/Impartial witness
6. Pharmacovigilance
7. SAE
8. ADR
9. SUSAR
10.BA
11.BE/BE/TE/CE
12.Plasma half life
13.Relative & Absolute Bioavailibility.
14. Parameters for BE Studies
15.Phase ‘0’
16.Randomization & its advantage
17.Blinding & its Types
18.CRO
19.Sponsor
20.Source Document
21.PSUR
22.Vulnerable Population
23.Schedule y
24.Generic Drugs
25.End Points
26.Protocol
27.CRF
28.HIPAA
29.SOP
30.PMS
31.IPR
32.
Enumerate
1. Principle of GCP
2. Sections of GCP
3. Topics of GCP
4. Parameter of Bioequivalence
5. Investigator’s Responsibilities (5)
6. Sponsor’s Responsibilities (5)
7. Ethics Committee Responsibilities (5)
8. Essential Documents required before/ during/ after the Trial
9. Monitors / CRA Responsibilities
10. Appendices of Schedule Y
11.Various dictionaries for clarification of ADR
12.Types of Preclinical Toxicity Studies
13.ICMR Guidelines
1.
Name the regulators body of:
a) India
b) Europe
c) UK
d) Australia
e) US
f) Japan
FDA form 1571 vs 1572
Form 44 vs Form 45 (of Schedule Y)
Form 12 vs Form II (of Schedule Y)
Phase II vs Phase III Studies
http://
Hello Friends....
Lets Join a New group... We Are CR Professionals...
We Are CR Professionals.... is group which will cover every aspect of Clinical Research.
It Will cover Any Clinical Research job vacancy ( govt. / Private) , all the Clinical Reasearch Stuff( Photos , videos, research Articles, notes , discussions etc....)
Regards
Dr. Gaurav Arora
http://www.facebook.com/
Questions asked in CRC & CRA Interviews
Define the following:
1. GCP
2. Clinical Research
3. Clinical Trial
4. Inform Consent Document
5. Inform Consent Process/LAR/Impartial witness
6. Pharmacovigilance
7. SAE
8. ADR
9. SUSAR
10.BA
11.BE/BE/TE/CE
12.Plasma half life
13.Relative & Absolute Bioavailibility.
14. Parameters for BE Studies
15.Phase ‘0’
16.Randomization & its advantage
17.Blinding & its Types
18.CRO
19.Sponsor
20.Source Document
21.PSUR
22.Vulnerable Population
23.Schedule y
24.Generic Drugs
25.End Points
26.Protocol
27.CRF
28.HIPAA
29.SOP
30.PMS
31.IPR
32.
Enumerate
1. Principle of GCP
2. Sections of GCP
3. Topics of GCP
4. Parameter of Bioequivalence
5. Investigator’s Responsibilities (5)
6. Sponsor’s Responsibilities (5)
7. Ethics Committee Responsibilities (5)
8. Essential Documents required before/ during/ after the Trial
9. Monitors / CRA Responsibilities
10. Appendices of Schedule Y
11.Various dictionaries for clarification of ADR
12.Types of Preclinical Toxicity Studies
13.ICMR Guidelines
1.
Name the regulators body of:
a) India
b) Europe
c) UK
d) Australia
e) US
f) Japan
FDA form 1571 vs 1572
Form 44 vs Form 45 (of Schedule Y)
Form 12 vs Form II (of Schedule Y)
Phase II vs Phase III Studies
