CLINICAL TRIAL ANALYST ,CDM,CRA INTERVIEW TIPS (fast preparation tips)

CLINICAL TRIAL ANALYST ,CDM,CRA INTERVIEW TIPS (fast preparation tips)

Topics need to be cover before appearing in the face to face interview(Technical Round),written test varies from one organization to other.

1. Basic pharmacology

• pharmacokinetics
• pharmacodynamics
• bio-availability 
• bio-equivalanace
• LD50/ED50
• Routes of Administration
•   Receptors(for example what type of receptor present in hear,lungs etc)

     2.Clinical Trials (t go through the links)

•  phases of clinical trials (4 phases) -http://www.clinicalresearch.pitt.edu/Content/docs/Comparison_of_Clinical_Trial_Phases.pdf

• Types of clinical Trialshttp://www.genetichealth.com/Resources_Types_of_Clinical_Trials.shtml 

     3.Regulatory authorities

•       Regulatory documents related to clinical trials in steps 

      drug discovery > preclinical testin(animals)>INDA(investigational newdrug application)>clinical studies
      PHASE I > PHASE II > PHASE III >NDA(new drug application)>PHASE IV
    (post marketing survillance) patent period will be 20 years ,after 20 years it will become generic drug >
     ANDA(abbrevated new drug application) then it will become generic drug

•        also go through the what are the regulatory bodies for different countries (eg:CDSCO-central drug standard controle organization)
• Documents required to submit the  Regulatory bodieswww.fda.gov/cder/regulatory/applications/ind_page_1.htm 
• http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/Approval Applications/NewDrugApplicationNDA/ 

       4.Drug discovery steps

       5.pharmacology drugs classificaton and mechanism of action

•   focus mainly on the drugs related to major organs(cardiovascular,diabetic,diuretics),anticancer drugs.

       6.pharmacovigilance from wikipedia
 
      TYPES OF QUESTIONS MAY ASK

1. Tell me about yourself  ? (as we know its common question)
2. how many phases in clinical trials?
3. after which phase we can apply for NDA?
4. after getting approval of NDA why we need to conduct phase iv?
5. what kind of data can we get in phase II trials?
6. tell me the different regulatory agencies for different countrys?
7. what is the patent period for orphan drugs?
8. what ANDA ?
9. what is innovatory drug and generic drug?
10. tell me the steps in drug discovery process?
11. drugs banned recently in phase iv clinical studies by FDA?
12. what is washout period?
13. what is the difference between type I and type II diabetics?
14. mechanism of action of few drugs?
15. what is cross over trail?
16. what is open blinded,randomized,double blined clinical trials?

                 
      NOTE:Questions depends on interviewer but topics could be mostly from above only .