1.      the term "Site Management Organization". How do they differ from "Contract Research Organizations?"

2.      What is acceptance number 0?

3.      how do we calculate about stability, and disintegration time?

4.      Is calculate about stability any more cost for investigation of antibiotic drug?

5.      How do we connect with "who"

6.      I cannot understand the terms ?chemistry-space metrics generated by the software

7.      is the typical CRO specialized on certain clinical trial types, is the specialization a foreseeable trend?

8.      Is there a way I can get a "hand-on" practice session with MedDRA, or a MedDRA auto-encoding system. 

9.      While clinical trails are ongoing are the pre-trials being continued at the same time? 

10.  Does QSR (Quality System Regulations)  already replace GMP Good Manufacture Practices officially?

11.  Can we consider that piece of vein as a biological device?

12.  Can you provide names of some FDA approved ERP software? Who uses it here in Toronto?

13.  Can you shed more light on the patent package adopted by Celgene that offered the drug enough protection and presumably made the production of Thalomid profitable?

14.  Is it importance to remember these rules like 21 CFR parts i.e. by their numbers and what they relate to? CFR is the abbreviation for ....?

15.  When talking about dose-response what do they mean by: comparisons in terms of blood/tissue levels vs mg/kg basis?

16.  Could you explain the term "compendial analytical method"Does it mean express method or qualitative (yes/no) analysis?

17.  What is the meaning of the word: con·com·i·tant?

18.  What does Concomitant test articles - mean?

19.  What does Covered clinical study mean?

20.  What is the declaration of Helsinki?

21.  What do Quality System , Quality Management, Quality Assurance , Quality control , and Regulatory Affairs mean?

22.  Please explain the « double dummy » concept while using a placebo in an active control trial.

23.  What is the definition of efficiency?

24.  Can we consider a small company manufacturing experimental drugs for
testing as an R&D company?

25.  What is HPLC?

26.  Could you please explain  what is banding effect as a result of cromatide exchange  test?

27.  When herbs have been proved to cure many common ailments, I feel that there must be some variety of herbs which may even prove beneficial in curing serious diseases like cancer, AIDS etc. Could you throw some light on this?

28.  How can you explain, that generally speaking, the price of Canadian drug is 30% to 80% less expensive than its American counterpart?

29.  How easy could I find the entry level position after graduation
from KRC having no medical or bio-tech education?

30.  It seems to me that companies need professionals with at least 5 years of Canadian experience
only and QA management is becoming more emergency service for problem
businesses.

31.  It seems to me that companies need professionals with at least 5 years of Canadian experience
only and QA management is becoming more emergency service for problem
businesses.

32.  What does in Vito mean?

33.  What are IPR Guidlines?

34.  Is the CRO held responsible for any of the adverse events during the trial?

35.  I came across the terms ‘ischemic wounds’ . Could you please brief me on the same?

36.  Is it possible to get hands on monitoring experience (go to site) as a volunteer?

37.  Who are the members of therapeutic product directorate and therapeutic product pannel,  of Health Canada? Who is enforcing the drugs and food act?

38.  What is the nursing rationale for assessing colour, warmth, movement and sensation. 

39.  I would like to ask about Ribavirin.  As I know, ribavirin inhibits viral m-RNA.  Is it possible use Ribavirin as an inhibitor against RNA replication of Dengue virus? 

40.  I would like to ask about Ribavirin.  As I know, ribavirin inhibits viral m-RNA.  Is it possible use Ribavirin as an inhibitor against RNA replication of Dengue virus? 

41.  Please explain phazes I-IV in a clinical trial 

42.  Can I find text of ISO in the Internet?

43.  What does Epidemiological mean?

44.  Can you please explain in simple terms what is safety data?

45.  What are the differences in the ICH GCP guidelines in conducting clinical trials for medical devices as compared to drugs? Also similar discussion for 'procedures'?

46.  What is Modified Hachinski?

47.  What is the meaning of SQL programming language?

48.  In 50 ㎍/ml, what does the symbol ‘㎍’ stand for?

49.  I came across the terms ‘ischemic wounds’ and ‘neodermis’. Could you please brief me on the same?

50.  How many CRA we need for 35,000 subject?

51.  Regarding the terms Investigational New Drug Application and Investigational New Drug Submission, are both one and the same or  is it different in terms of purpose?

52.  Is  FDA  the authorizing committee for drugs only in the US or does it have powers/function in other countries as well?

53.  Do all pharmacy companies follow the regulations of a Drug Authorizing Committee before releasing a drug into the market?

54.I have a question regarding the EGF03/CT-032 Project, namely regarding the confidentiality of the projects in general. Is it possible to write a letter to a potential Investigator, without breaching the confidentiality rule?

55.  What is the Difference between Adverse Drug Reactions and Adverse Drug Events?

56.Suppose an investigational drug in its Phase I clinical trial shows Serious
Adverse effects, for example, Jaundice in
3%,Hypotension in 4%, edema in 5%, respiratory suppression in 10%, coma in
1% etc. Can it be suggested for its Phase II clinical trials?

57.  What do we exactly mean by  Inclusion and exclusion criteria in a protocol?

58.  What is SOPs?

59. Is there any provision for other countries to join ICH or is it a closed organisation?

60.  Please explain the term ‘exogenous xenobiotic’ and give some examples.  Is there any such thing as endogenous xenobiotic?

61.  What are negative and positive control groups ?

62. Could you please explain what exactly is Assay Sensitivity and its role in Equivalence trials.I have checked the FAQs but the explanation there is some what same as given in text. It is not explicit.

63. What do you mean when u say data should  be 'contemporaneous'?

64.  What are biometric-based electronic signatures ?

65.  What is a Minimum Data Set or MDS in relation to clinical research?

66.  Study Planning Activities?

67. Do you know any links to good web-sites with complete manual on statistic
assay?

68.  What is NIH policy?

69.  "What is 'Noninferiority  Trial'?"

70.  A non-therapeutic trial (i.e., a trial in which there is no anticipated direct clinical benefit to the subject)
Under what circumstances would one do this sort of trial?

71.  Compassionate Use Defined

72.  I need explanations about "CONCURRENT VALIDATION"

73.  Could you please define statistical process control ?

74. I was searching on the Apotex company site and I didn't understand the following abreviations regarding a Drug Informartion Associate Position in Apotex:

75.  Cytotoxic Agents?

76. Definition for Dalton

77.  Definitions of Regimen and Comparator

78.  What is the difference between local and central IRBs?

79.  Does QSR (Quality System Regulations)  already replace GMP Good Manufacture Practices officially?

80.How much (in terms of percentage) it would cost to study the efficacy requirement of a drug compared to the safety requirement of the same?

81.  Could you please give 1 or 2 examples of non-therapeutic trial highlighting the importance of this type of trial?

82. In a double blinded study,at the end on trial how will we come to know that which group was getting effective treatment and which is getting placebo

83. I do not understand the word assay.

84. Are there ever situations where the treatment or device on trial is so ineffective as to lead to further deterioration in the subjects condition, and what happens in situations like these?

85.  Would muscular dystrophy be considered a cachectic and ataxic disorder?

86.I will be thankful if you provide a concrete example of no-treatment
clinical group and its advantages and significance

87.  What does include Pharmaceutical Dosage Formulation and Stability Testing ?

88. What does include Pharmaceutical Dosage Formulation and Stability Testing ?

89. What is PK/PD Data ?

90. How would ARs are reported by trial participants AFTER the trial is complete and marketing approval received ?

91.Publication of trial results by investigator: What is the current status of this situation?

92.  I am not sure that I understood the corectly definition of BPR.

93.  How is Quality of life and Pharmacoeconomics related to clinical trials?

94.  Please find below the passage of text where the term "analyte" appears. Please explain this term.

95.What are differences between quality system and quality function?

96.  Can the sponsor request changes to the study timelines (i.e. request less time or more time for the study) ?

97.  Could you please explain some of  the challenges which would be faced by the pharmaceutical companies in the future?

98.Label of investigational drug

99.  What are Recrudescence, Quiescent

100.What does " crossover studies " mean?

101.What does "Media fills" mean?

102.What does EXCIPIENT mean?

103.What is "covariates influencing outcome"?

104.When I see "endpoint"...

105.What "Recombinant" could mean?

106.What is Apheresis?

107.What is compromised immune system?

108.What is constant error?

109.What is IVRS in data management of clinical trials?

110.What is LTPD, AQL, OC curve ?

111. What is MWCB

112. What isotopes are usually used for molecule labeling? Is it related to
the radiopharmacy?

113. What the deference between auditor and inspector?

114. What's a 1572 form supposed to do and what regulation is it a part of?

115. I have a question on patent

116. Please explain the terms "Cachectic", "Ataxia" and "Athetosis".

117. What is the fraction defective?

118. I would like to know, what happened to the rest 40% of treated mice,which weren't as lucky as survival 60%?

119. People's immune system attacks the mutant virus before it could penetrate and spread through a brain tumour?

120. Evidence of compound stability

121. What do TBF and TEWL stand for?

122. Could you please explain the difference in duties and responsibilities of monitors and auditors in a clinical trial?

123. Report on the ontario submission requirements

124. How to understand this statement (from Session 25):" Volunteer participation by women of all races, ages and ethnicities is essential, if researchers are to find the best treatment regimens." ?

125. Water vascular system is based on osmosis in annelids

126. We would like to understand very detailed information about biotransformation of alcohols & intoxication of alcohols.

127. What are master files?

128. What does Class 100,000 mean?

129. What does include Pharmaceutical Dosage Formulation and Stability Testing?

130. What does soft information mean?

131. What is a generic drug?

132. What is Cytochrome P450 enzimes?

133. What is DHHS regulations?

134. What is GMP?

135. What is HPLC?

136. What is ISS/ISE?

137. What is NCR paper?

138. What is NMR? How does it differ from X-ray Crystallography?

139. What is selective blocker of Hi receptors?

140. What is 'unblinding'?

141. What do they mean when they talk about « withdrawing the conventional treatment by tapering »?

142. Whats the side effects of oxyphencyclimine hydrochloride.

143. Where can we find about HIPAA privacy rules?

144. Why grant patent for medication for particular indications only?

145. Why bacteriostatic and bacteriocidals can't be used together?

146. How long does the protection provided by patents for a new compound, in this case therapeutic one, last?

147. I want to know the safety pharmacology studies are conduct as a preclinical study?

149. Are there any laboratory testing required, I noticed in the safety section under Phase II trial conducted in Korea, they mentioned something about laboratory tests, if there are what tests and during what visits?

150. Are your diplomas recognised by the majority of employers?

151. "Does FDA/TPD approve  a drug based on meta analysis using data obtained from various studies in different countries, along with or without a small size (patient number) clinical trial in North America  ?"

153. In a  "Clinical SAS programmers" ad I saw the following line:

154. What about the Canadian TPD and how close are they in regulating things like computerized data entry and investigative reports.

155. How do I go to next session?

156. How to calculate healing rates in EGF project ?

157. How to save the session?

158. How to start EGF project?

159. How to start PU CR project:

160. In CROs or in any research/biotechnology companies, how many Clinical Data
Managers are there? and how many Clinical Data Coordinators?

161. Are there any safety measurements other than adverse events recording?

162. Please informe me about the meaning of: CRL,  SAS,  IDD.

164. On what basis do the FDA wants financial disclosure for the spouse and children before the start of the trial?

165. Please explain the active centers of enzymes?

166. Please give an illustration of in vivo and invitro experiment.