What Does An SGML File Look Like?

SGML, or Standard Generalized Markup Language, is an international standard for the description of marked-up electronic text. SGML is a meta language, which is a means of formally describing a language. More specifically, SGML is a markup language that has been used in the publishing industry to associate document format with text.
A basic design goal of SGML was to ensure that documents encoded according to its provisions should be transportable from one hardware and software environment to another without loss of information. The structure of SGML is based on a grouping of sections and elements that are annotated by start and end tags. Tags are user-friendly phrases used to indicate the data elements contained within the tags. For example:
19690218
In this example, the starting and ending tags "patient birthdate" indicate that the data within the tags is the patient's birthdate. The relationship and order of data elements is further defined by document type definition (DTD). DTDs are document-specific specifications for the structure of an SGML document. In the following example, the DTD has specified that the order of the information be presented as:
19690218/patientbirthdate> 29 years .
Using the above example the data must be presented in the following order to be in conformance with the DTD:
Patient birth date
Patient onset age
Patient onset age unit
If the data elements are presented in any other order (e.g., patient onset age, patient onset age unit, patient birth date) the elements are not in conformance with the SGML DTD for the document.
For electronic submission of adverse event data, a specific SGML DTD has been specified by the ICH. The ICH ICSR DTD defines the specific data elements to be included for electronic submission of adverse event data, the order of the elements, and their interrelationship.

What is the difference between E2B and E2BM?

E2B is the international standard for the transmittal of electronic safety data signed as an ICH Step 4 document in July1997. E2BM clarifies and resolves issues raised in the three regional pilot studies. The revised document (E2BM) is intended to further advance the electronic exchange of safety information and approach a true EDI (Electronic Data Interchange) standard. The E2B document is implemented by M2 Specification Version 2.24 DTD Version 2.0. The E2BM document is implemented by M2 Specification Version 2.3 DTD Version 2.1

Implementation Guide for FDA Medical Device Reporting

Here we go with the link:

http://www.fda.gov/downloads/ForIndustry/DataStandards/IndividualCaseSafetyReports/UCM161178.pdf

Timeframe for reporting Adverse Events

1. 24 hour notice – When sponsor is told by PI- Death – Regardless of relatedness or expectedness

2.15 day notice- When sponsor is told by PI- Adverse Events that are either unanticipated or serious and  related or possibly related

3.Within 5 days of receipt - PI or Sponsor- Safety Reports (any adverse experience associated with use of the drug that is both serious and unexpected, Any finding from tests in laboratory animals that suggests a
significant risk for human subjects including reports of mutagenicity.

4.Periodic - PI- All other events must be tabulated for submission at the time of continuing review or final report.

COMPANY CORE SAFETY INFORMATION

It is the reference information by which listed and unlisted are deter-mined for the purpose of periodic reporting for marketed products, but not by which expected and unexpected are determined for expedited reporting.All relevant safety information contained in the Company Core Data Sheet prepared by the Marketing Authorisation Holder and which the Marketing Authorisation Holder requires to be listed in all countries where the company markets the product, except when the local regulatory authority specifically requires a modification.

Individual Case Safety Report in Pharmacovigilance

Information to validate an Individual Case Safety Report in Pharmacovigilance when they receive it from a source( Clinical Trial & Spontaneous):

The criteria for a valid case are:

● an identifiable patient;

● a suspect drug;

● a suspect reaction;

● an identifiable HCP reporter.

In the context of expedited reporting, day zero should be considered the day on which the minimum criteria for a reportable adverse reaction report becomes available to the MAH.

Indian GCP Guidelines

• Evolved with consideration of WHO, ICH, USFDA , European GCP and Ethical Guidelines of Biomedical Research on Human Subjects of ICMR.
• Should be followed for carrying out biomedical research in India at all stages of drug development,whether prior or subsequent to product registration in India

Ethical Principles of Indian GCP:

Essentiality, Voluntariness, Informed consent and community agreement, Non-exploitation, Privacy and confidentiality , Precaution & risk minimisation , Professional competence, Accountability and transparency, Maximisation of the public interest and Distributive justice, Institutional arrangements , Public domain Totality of responsibility,  Compliance

Declaration of Helsinki 1964

• Duty of physician to protect the life, health, privacy and dignity of the human subject
• Review of proposed research by independent ethics committee
• Medical research involving human subjects only by scientifically qualified persons and under the supervision of a clinically competent medical person
• Physician to obtain the subject’s freely-given consent, preferably in writing
• Stress on publication of results - negative or positive

Nuremberg Code

Nuremberg Code(1947)

• Voluntary consent
• Anticipate scientific benefits
• Benefits outweigh risks
• Animal experiments first
• Avoid suffering
• No intentional death or disability
• Protection from harm
• Subject free to stop
• Qualified investigators
• Investigator will stop if harm occurs

Types of Clinical Trials

Types of trials:

Phase I:

First time a new drug or regimen is tested on humans
Few participants (say <30)
Primary aims are to find a dose with an acceptable level of safety, and examine the biological and  pharmacological effects

Phase II :

Not too large (say 30–70 people)
Aim is to obtain a preliminary estimate of efficacy
Not designed to determine whether a new treatment works
Produces data in each of the trial arms, that could be used to design a phase III trial

Phase III:

Must be randomised and with a comparison (control) group
Relatively large (usually several hundred or thousand people)
Aim is to provide a definitive answer on whether a new treatment is better than the control group, or is similarly effective but there are other advantages

Phase IV:

Relatively large (usually several hundred or thousand people)
Used to continue to monitor efficacy and safety in the population once the new treatment has been adopted into routine practice.

Characteristics of a Good Case Report

Good case reports include the following elements:

1. Description of the adverse events or disease experience, including time to onset of signs or symptoms;
2. Suspected and concomitant product therapy details (i.e., dose, lot number, schedule, dates, duration), including over-the-counter medications, dietary supplements, and recently discontinued medications;
3. Patient characteristics, including demographic information (e.g., age, race, sex), baseline medical condition prior to product therapy, co-morbid conditions, use of concomitant medications, relevant family history of disease, and presence of other risk factors;
4. Documentation of the diagnosis of the events, including methods used to make the diagnosis;
5. Clinical course of the event and patient outcomes (e.g., hospitalization or death);
6. Relevant therapeutic measures and laboratory data at baseline, during therapy, and subsequent to therapy, including blood levels, as appropriate;
7. Information about response to dechallenge and rechallenge; and
8. Any other relevant information (e.g., other details relating to the event or information on benefits received by the patient, if important to the assessment of the event).

Medical Dictionary for Regulatory Activities, MedDRA

The dictionary includes terms that are relevant to all phases involving man in the development and post-authorization safety surveillance of medicines and to the health effects of  medical devices (Maintenance and Support Services Organization).

The terms in MedDRA cover medical diagnoses, symptoms and signs, adverse reactions, therapeutic indications, the names and qualitative findings from laboratory, radiological and other investigations, surgical and medical procedures, and social circumstances. It  does not include a drug or device nomenclature, nor does it include terms covering study design, pharmacokinetics or patient demographics. It does not allow for adjectives such as those describing disease severity or frequency, although qualifiers such as acute, chronic, recurrent are included in terms when clinically relevant. There is a restricted range of terms for describing aggravation or exacerbation of medical conditions.

In the pre-registration phases of a product’s life cycle, MedDRA may be used, for example, for recording adverse events and baseline medical history in clinical trials, in the analysis and tabulations of data from these and in the expedited submission of adverse event data to government regulatory authorities. It may be used in constructing standard product information, such as summaries of product characteristics (SPCs) or product labelling and in registration files in support of applications for marketing authorization/new drug applications. After licensing, MedDRA is used in pharmacovigilance for the continuing evaluation of drug safety, for both expedited and periodic safety reporting

An Article on Pharmacovigilance in Vaccines

Here you go with the link on Pharmacovigilance in Vaccines -

http://www.ijp-online.com/article.asp?issn=0253-7613;year=2010;volume=42;issue=2;spage=117;epage=117;aulast=Budhiraja

Signal in Pharmacovigilance

A signal is a set of data constituting a hypothesis that is relevant to the rational and safe use of a drug in humans-  R. Meyboom et al. 1997

A signal is reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously- Edwards et al. 2000

Signal Generation:
i) three convincing ADR-reports
ii) # specified ADR-Reports/ # Prescriptions
iii)# specified ADR-Reports (PRRs)/ all Reports
iv) # specified Reports / Exposed Persons //Background Incidence

Purple Guide in Pharmacovigilance

In November 2008, the MHRA issued the 'Good Pharmacovigilance Practice Guide'. Also known as 'The Purple Guide  

Commercial pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to identifying new information about hazards associated with medicines and preventing harm to patients. Pharmacovigilance is particularly concerned with adverse drug reactions. This text complements current legislation and guidance and provides practical advice about achieving an appropriate system of pharmacovigilance.

This guide was primarily developed for UK Marketing Authorisation Holders (MAHs). It will also be of great interest to pharmacovigilance consultants. The use of third-party service providers for pharmacovigilance activities is quite common, particularly for smaller organisations which do not have in-house pharmacovigilance expertise. The guide references European legislation and guidance and so should be applicable across Europe.

 

Schedule Y

The legislative requirements of pharmacovigilance in India are guided by specifications of  Schedule Y7 of the DC Act and the DC Rules thereto. It sets forth, for example, regulations pertaining to preclinical and clinical studies for the development of a new drug, as well as clinical trial requirements for the import,manufacture and receipt of marketing approval for a new drug in India. It also includes the approval procedures for clinical trial and other documentation to be submitted with the sponsor’s application, with attention to the responsibilities of the sponsor, requirements of informed consent, responsibilities of Ethics Committees and details of the four phases of trials. Schedule Y also requires compliance with Good Clinical Practice Guidelines issued by CDSCO, the Directorate General of Health Services and the government of India.


Global Pharmacovigilance Laws & Regulations: The Essential Reference 156 Schedule Y underwent thorough review several years ago. Its latest amendment, dated January 20, 2005, aimed to underscore the continued commitment of DCGI to ensure pharmaceutical companies’ adequate compliance with pharmacovigilance obligations. The amended Schedule Y also attempts to better define the responsibilities of pharmaceutical companies for their marketed products, as well as responsibilities for reporting adverse events from clinical trials. For a complete understanding of reporting responsibilities specific to clinical trials conducted in India, Schedule Y should be read along with Rules 122A,122B, 122D, 122DA, 122DA and 122E of the DC Rules.


As specified in Schedule Y, a pharmaceutical company holding one or more marketing  licenses in India should ensure that it has in place an adequate pharmacovigilance system for its product(s). When two or more marketed products are identical in all aspects except  their trade names, each pharmaceutical company holding a marketing license is obliged to independently meet their own pharmacovigilance obligations. This includes the establishment and maintenance of appropriate systems to collect, collate and evaluate information
about suspected adverse reactions. A pharmaceutical company can achieve this either by setting up in-house systems for pharmacovigilance or by entering into contractual agreements  with Contract Research Organizations (CROs) specializing in pharmacovigilance  functions.

Preferred Name

Drugs containing the same active ingredient(s) are referred to by Preferred name – the international non-proprietary name (INN) in English for single ingredient drugs (or other approved name, if there is no INN). For multiple ingredient drugs, the Preferred name is the first reported drug name of a given combination.

N Single ingredient drug non-proprietary name
T Single ingredient drug proprietary name
K Single ingredient drug chemical name
R Single ingredient drug code number
M Multiple ingredient drug proprietary name
X Multiple ingredient drug non-proprietary name
U Non-specific name, from ATC texts (such as NSAID or benzodiazepine)

Weber Effect in PV

“Weber Effect”: The peak reporting for events in a drug on market occurs within the first 2 years of approval (Hartnell, & Wilson, 2004) during the initial 5 year marketing period.

Dr J. C. P. Weber plotted the mean number of ADR reports for seven non-steroidal anti-inflammatory drugs (NSAIDs) over the first 5 years of marketing and showed that they peaked at 2 years and then declined rapidly. This has been called the Weber curve (Weber, 1984). It cannot be presumed that it will apply in all circumstances; but it did apply to antiinfective, endocrine, pulmonary and cardiovascular drugs (Brodovicz et al., 2001).When 10 drugs on the French market, which gave rise to approximately 100 spontaneous reports each during the first 4 years of marketing, were examined the reports peaked at 1 year and then decreased

Semmelweis-Contribution to Clinical Trials

Semmelweis, 1848 – 1863: He studied puerperal sepsis in Vienna over the protestations of his chief; he noted that the sepsis rate was three times higher in Division 1 than in Division 2; Divisions identical except medical students taught in Division 1, Midwives in Division 2.


Death of a friend following infection of an autopsy-related wound led to his primary hypothesis that the infection was transported from the autopsy room to uninfected patients by the students.

Semmelweis - Experimental Design:

Students to wash hands in chlorinated lime solution.

Mortality rate dropped from 18.3% to 1.3% per year; in some months in 1848 the mortality rate was 0%.

His chief did not believe his data; one year later he was fired.

He returned to Budapest, Hungary where he was placed in charge of an obstetrical unit plagued with an epidemic of puerperal sepsis. He repeated his earlier experiment and again the mortality rate declined precipitously (mortality remained less than 1% during his six-year tenure vs. 10 to 15% in Vienna and Prague).His major paper, “The etiology, understanding, and prevention of puerperal sepsis” was rejected by the Vienna Medical Journal and he ultimately had to pay to get his work published.

ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL

The documents which individually and collectively allow the evaluation of the conduct of a study and the quality of the data generated. These documents demonstrate the compliance (or otherwise) of the Investigator, Sponsor and Monitor with the GCP and with other applicable regulatory requirements.

Essential Documents are needed for Sponsor’s independent audit function and inspection by the Regulatory Authority.
The various Essential Documents needed for different stages of the study are classified under three groups:

1. before the clinical phase of the study commences,
2. during the clinical conduct of the study, and
3. after completion or termination of the study.
The documents may be combined but their individual elements should be readily identifiable.
Master files containing all documents pertaining to the study should be created at the beginning of the study, at the Investigator / Institution site, Sponsor’s office, Ethics committee’s office and the CRO’s office.

Abbreviation: I- Investigator / Institute, S - Sponsor,C - CRO, E – IEC

Before the Clinical Phase of the Trial Commences :Investigators, CRO,Sponsor, IEC should have a copy of all the documents listed below.
Investigator’s brochure ( To document that relevant and current scientific information about the investigational product has been provided to the investigator )
Signed protocol and amendments, if any, and sample case report form(CRF)( To document investigator and sponsor agreement to the protocol/amendment(s) and CRF
Information given to trial subject ( informed consent form)

Any other written information (To document that subjects will be given appropriate information (content and wording) to support their ability to give fully informed consent )

Advertisement for subject recruitment (To document that recruitment measures are appropriate and not coercive )

Financial aspects of the trial(To document the financial agreement between the investigator/institution and the sponsor for the trial )

Insurance statement (To document that compensation to subject(s) for trial-related injury will be available
Dated, documented approval / favourable opinion of independent ethics committee (IEC) of the following:

protocol and any amendments, CRF (if applicable), informed consent form(s), any other written information to be provided to the subject(s), advertisement for subject recruitment, Subject compensation, any other documents given approval / favourable opinion

Independent ethics committee composition( To document that the IEC is constituted in agreement with GCP)
Regulatory authority(ies) authorisation / approval / notification of protocol(To document appropriate authorisation / approval / notification by the regulatory authority(ies) has been obtained prior to initiation of the trial in compliance with the applicable regulatory requirement(s))
Curriculum vitae and/or other relevant documents evidencing qualifications of Investigator(s) and Co-Investigator / Sub-Investigator(s)
Normal value(s) / range(s) for medical / laboratory / technical procedure(s) and/or test(s) included in the protocol

Sample of label(s) attached to investigational product container(s)( To document compliance with applicable labelling regulations and appropriateness of instructions provided to the subjects )- I,E,C,S.
Instructions for handling of investigational product(s) and trial-related materials(To document instructions needed to ensure proper storage, packaging, dispensing and disposition of investigational products and trial-related materials)

Shipping records for investigational product(s) and trial-related materials( To document shipment dates, batch numbers and method of shipment of investigational product(s) and trial-related materials. Allows tracking of product batch, review of shipping conditions, and accountability)
Certificate(s) of analysis of investigational product(s) shipped( To document identity, purity, and strength of investigational product(s) to be used in the trial)
Decoding procedures for blinded trials( in case of an emergency, identity of blinded investigational product can be revealed without breaking the blind for the remaining subject’s treatment )

Master randomisation list
Pre-trial monitoring report ( To document that the site is suitable for trial (may be combined with Trial initiation monitoring report)
Trial initiation monitoring report (To document that the trial procedures were reviewed with the investigator and the investigator’s trial staff ).

During the Clinical Conduct of the Trial:

In addition to having on file the above documents, the following should be added to the files during the trial as evidence that all new relevant information is documented as it becomes available.

Investigator’s brochure updates

Any revision to: protocol amendment(s) and CRF , informed consent form, any other written information provided to subjects, advertisement for subject recruitment.

Dated, documented approval / favourable opinion of Independent ethics committee (IEC) of the following: protocol amendment(s), revision(s) of: informed consent form, any other written

information provided to subject advertisement for subject recruitment(if used) any other documents given approval / favourable opinion,continuing review of trial.

Regulatory authority(ies) authorisations / approvals / notifications where required for: protocol amendment(s) and other documents -I,S,C,E

Curriculum vitae for new investigator(s) and / or sub- investigator(s) -I,S,C,E

Updates to normal value(s) / range(s) for medical / laboratory / technical procedure(s) / test(s) included in the protocol-I,S,C

Medical / laboratory / technical procedures / tests- certification or accreditation or established quality control and / or external quality assessment or other validation-I,S,C

Documentation of investigational product(s) and trial-related material shipment -I,S,C

Certificate(s) of analysis for new batches of investigational products -S,C

Monitoring visit reports -S,C

Relevant communications other than site visits( letters, meeting notes, notes of telephone calls)- To document any agreements or significant discussions regarding trial administration, protocol violations, trial conduct, adverse event (AE) reporting -I,C

Signed informed consent forms – I(Original), S& C(Copy)

Source documents – I(Original), S& C(Copy)

Signed, dated and completed case report forms (CRF) – I,E,C (Copy)

Documentation of CRF corrections- I(Original), S& C(Copy)

Notification by originating investigator to sponsor of serious adverse events and related reports- I,E,C,S

Notification by sponsor and/or investigator, where applicable, to regulatory authority(ies) and IEC(s) of unexpected serious adverse drug reactions and of other- I,E,C,S

Notification by sponsor to investigators of safety information-I,E,C,S

Interim or annual reports to IEC and authority(ies)-I,E,C,S

Subject screening log -I,E,C,S

Subject identification code list-I,E,C,S

Subject enrolment log -I,E,C,S

Investigational products accountability at the site -I,E,C,S

Signature sheet -I,E,C,S

Record of retained body fluids/ tissue samples -I,E,C,S


After Completion or Termination of the Trial :

After completion or termination of the trial, all of the documents identified should be in the file together with the following :

Investigational product(s) accountability at site- I,C,S

Documentation of investigational product destruction-I,C,S

Completed subject identification code list-I,C,S

Audit certificate- C,S

Final trial close-out monitoring report- C,S

Treatment allocation and decoding documentation(Returned to sponsor to document any decoding that may have occurred )- C,S

Final report by investigator to IEC where required, and where applicable, to the regulatory authority(ies) – I,E,C,S

Clinical study report – I,E,C,S

Initiation of Experimental Design in Clinical Research

James Lind – He was the one who was responsible for initiating Experimental Design in Clinical Trials in 1753.Scurvy was a major health problem for the British Navy in the 1700’s.


William Harvey had recommended lemons to treat scurvy, but had argued that the therapeutic effect was a result of the acid in the fruit. James Lind, a naval surgeon, conducted a

clinical trial in 1747 to assess the utility of three therapies for scurvy.

Women in Clinical Research

1.Florence Nightingale (1820-1910).Born in Florence, Italy

 

• Famous work in nursing 
• Accomplished mathematician 
• Math expertise dramatized needless deaths caused by unsanitary conditions in hospitals and need for reform
• Major contributions during Crimean War in promoting sanitary conditions for soldiers

 

2.Marie Curie (1867 – 1934) Born in Warsaw, Poland

 

Accomplishments:

• Discovery of radium
• Realization that radioactivity is an intrinsic atomic property of matter
• Pioneered a mobile x-ray unit for the French army in WWI
• Founded a radiological school for nurses
• With her husband, she was awarded half of the Nobel Prize for Physics in 1903, for their study into the spontaneous radiation discovered by Becquerel (awarded the other half of the Prize)
• In 1911 she received a second Nobel Prize in Chemistry, in recognition of her work in radioactivity.
• Daughter, Irene Joliot-Curie, was awarded the Nobel Prize for chemistry in 1935 jointly with her husband for their discovery of artificial radioactivity

Blinding

Torald Sollmann suggested a placebo control and blinded observer as a solution to investigator bias as early as 1930.

Blindfold Tests: widely used by advertisers and consumer groups in the 1930s and 1940s

Randomization

This concept was first put forth by Sir Ronald Aylmer Fisher (1890-1962).

• Introduced application of statistics to experimental design
• Farming and plant fertility: concept of randomization and analysis of variance

History of Informed Consent

In 1767: Slater V.Baker & Stapleton was the person who said that “…it is reasonable that a patient should be told what is about to be done to him.”

In 1898: Osler, William said “To deliberately inject a poison of known high degree of virulency into a human being, unless you obtain a man’s sanction…is criminal.” (In response to an oral presentation by Giuseppe Sanarelli on discovery of the etiologic agent of yellow fever)

Clinical Trials- Definition and Types

Clinical Trial/research studies gives a clinician many answers to questions from the point of prevention, detection, diagnosis, control and treatment of illness or a condition such as cancer. It is used not only in relation to a new drug but also to study equipments, devices, treatments, interventions etc.The following is the list of  the different kinds of trials:

Treatment trials - Finding newer and more effective treatment approaches and options.

Prevention trials - Finding new ways to prevent a specific disease from developing in people who have not previously had the disease or to prevent the recurrence of the disease in those already having the disease.

Diagnostic trials - Developing new trials or procedures to identify a particular disease or health condition earlier or more accurately.

Screening trials - Detecting diseases or health conditions before they start to appear as symptoms.

Supportive care / Quality of life trials - Exploring new interventions that can improve the quality of life and comfort level of individuals suffering from chronic disease conditions.

Misspelled words- Module 1(Letter A)

We will first start with the alphabet A:

Acceptable - suffix pronounced -êbl but sometimes spelled -ible, sometimes -able. Just remember to accept any table offered to you.

Accidentally - It is no accident that the test for adverbs on -ly is whether they come from an adjective on -al ("accidental" in this case). If so, the -al has to be in the spelling. No publical, then publicly.

Accommodate - Remember, this word is large enough to accommodate both a double "c" AND a double "m." 

Acquire - Try to acquire the knowledge that this word and the next began with the prefix ad- but the [d] converts to [c] before [q].

Acquit - See the previous discussion.

A lot - Two words! Hopefully, you won't have to allot a lot of time to this problem.

Amateur - Amateurs need not be mature: this word ends on the French suffix -eur (the equivalent of English -er).

Apparent - A parent need not be apparent but "apparent" must pay the rent, so remember this word always has the rent.

Argument - Let's not argue about the loss of this verb's silent [e] before the suffix -ment.

Atheist - Lord help you remember that this word comprises the prefix a- "not" + the "god" (also in the-ology) + -ist "one who believes."

Graduate Record Exam- Analogy

Analogy Practice Test Questions with Key:

1. DRIP : GUSH
A. cry : laugh
B. curl : roll
C. stream : tributary
D. dent : destroy
E. bend : angle
2. WALK : LEGS
A. blink : eyes
B. chew : mouth
C. dress : hem
D. cover : book
E. grind : nose
3. ENFRANCHISE : SLAVERY
A. equation : mathematics
B. liberate : confine
C. bondage : subjugation
D. appeasement : unreasonable
E. anatomy : physiology
4. UNION JACK : VEXILLOLOGY
A. toad : ornithology
B. turtle : microbiology
C. gymnosperms : botany
D. friend : home economics
E. algae : zoology
5. TOPAZ : YELLOW
A. diamond : carat
B. jeweler : clarity
C. sapphire : red
D. amethyst : purple
E. amber : blue
6. LUMEN : BRIGHTNESS
A. candle : light
B. density : darkness
C. nickel : metal
D. inches : length
E. color : hue
7. MACERATION : LIQUID
A. sublimation : gas
B. evaporation : humidity
C. trail : path
D. erosion : weather
E. decision : distraction
8. CLUMSY : BOTCH
A. wicked :insinuate
B. strict:pamper
C. willful:heed
D. clever:eradicate
E. lazy:shirk
9. FUGITIVE : FLEE
A. parasite:foster
B. braggart:boast
C. sage:stifle
D. bystander:procure
E. firebrand:quibble
10. CHRONOLOGICAL : TIME
A. virtual:truth
B. abnormal:value
C. marginal:knowledge
D. ordinal:place
E. coincidental:health
11. SOOT : GRIMY
A. frost:transparent
B. sunshine:fruitless
C. rain:sodden
D. pall:gaudy
E. dust:radiant
12. MORBID : UNFAVORABLE
A. reputable:favorable
B. maternal:unfavorable
C. disputatious:favorable
D. vigilant:unfavorable
E. lax:favorable
13. SULLEN : BROOD
A. lethargic:cavort
B. regal:cringe
C. docile: obey
D. poised:blunder
E. despondent:laugh
14. AUTHOR : LITERATE
A. cynic:guillible
B. hothead:prudent
C. saint:notorious
D. judge:impartial
E. doctor:fallible
15. MASSIVE : BULK
A. ultimate:magnitude
B. trival:importance
C. anonymous:luster
D. interminable:legacy
E. gigantic:size
16. ENTICE : REPEL
A. germinate:sprout
B. flourish:fade
C. officiate:preside
D. lubricate:grease
E. implore:entreat
17. HUMDRUM : BORE
A. grim:amuse
B. nutritious:sicken
C. stodgy:excite
D. heartrending:move
E. pending:worry
18. HOSPITABLE : COURTESY
A. morbid:cheerfulness
B. vindictive:spite
C. leisurely:haste
D. infamous:honor
E. despondent:glee
19. REINFORCE : STRONGER
A. abound: lesser
B. dismantle: longer
C. wilt: higher
D. shirk: greater
E. erode: weaker
20. BRAGGART : MODESTY
A. fledgling:experience
B. embezzler: greed
C. wallflower: timidity
D. invalid: malady
E. candidate:ambititon
Answer Key
1. D
2. B
3. B
4. C
5. D
6. D
7. D
8. E
9. B
10. D
11. C
12. A
13. C
14. D
15. E
16. B
17. D
18. B
19. E
20. A

Pharmacovigilance- A Practical Guide for Beginners

This book would be of great  help to those who are yet to start their career in the Pharmacovigilance domain.

 http://pdfcast.org/pdf/a-practical-guide-on-pharmacovigilance-for-beginners

Link to Electronic Journals, Books and Newspapers

 I guess this link would be of great help to people who have a passion to read newspapers or are curious to know things happening in the world.

 http://library.pittstate.edu/db/#e-news

Medical Research Ethics

In 1900, informed consent for participation in research was recorded, the Nuremberg Code highlighted the essentiality of voluntariness of this consent.

The first International Statement on the ethics of medical research using human subjects namely, the Nuremberg Code was formulated in 1947(Post World War II Nuremberg Trials 1946-1947).German physicians conducted pseudoscientific medical experiments on thousands of concentration camp prisoners without their consent.Most prisoners died or were permanently crippled as a result.

In 1948, Universal Declaration of Human Rights (adopted by the General Assembly of the United Nations) expressed concern about rights of human beings being subjected to involuntary maltreatment.

In 1966, the International Covenant on Civil and Political Rights specifically stated, ‘No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his consent to medical or scientific treatment.’

In 1964 at Helsinki, the World Medical Association formulated general principles and specific guidelines on use of human subjects in medical research, known as the Helsinki Declaration, which was revised from time to time.

1979-  Belmont Report (issued by U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research)

1. Principle of Respect: Recognized autonomy of humans and requires clear informed consent.
2. Principles of Beneficence: Research mush be shown to be beneficial and reflect the Hippocratic idea of do no harm.
3. Principle of Justice: The benefits to some must be balanced against the risks of subjects.

 In February 1980, the Indian Council of Medical Research released a ‘Policy Statement on Ethical Considerations involved in Research on Human Subjects’ for the benefit of all those involved in clinical research in India

  

In 1982, the World Health Organisation (WHO) and the CIOMS issued the ‘Proposed International Guidelines for Biomedical Research involving Human Subjects.’

In 1991,CIOMS brought out the ‘International Guidelines for Ethical Review in Epidemiological studies’

  

‘International Ethical Guidelines for Biomedical Research involving Human Subjects’ was put in to force in 1993.

DECLARATION OF HELSINKI:HISTORICAL AND CONTEMPORARY PERSPECTIVES”

This link will give you information about the Declaration of Helsinki:

http://www.wma.net/en/20activities/10ethics/10helsinki/draft_historical_contemporary_perspectives.pdf

Clinical Research Dictionary

 Download Link:

http://www.michr.umich.edu/tools/dictionary/G-I.htm

Medical Writing ebook- Mastering Scientific and Medical Writing A Self-help Guide

http://rapidshare.com/files/158959846/Rogers_Mastering_Scientific_and_Medical_Writing-A_Self-Help_Guide.pdf.html