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1. DRUGS (e.g., prescriptions, OTCs, generics)
2. Biologics (e.g., vaccines, blood products)
3. Medical devices (e.g., pacemakers, contact LENSES)
4. Food (e.g., nutrition, dietary supplements)
5. ANIMAL FEED and drugs (e.g., livestock, pets)
6. Cosmetics (e.g., SAFETY, labeling)
7. Radiation emitting products (e.g., cell phones, lasers)

A CRO or Clinical Research ORGANIZATION is that which is contracted by the sponsor to conduct and MONITOR the trial. It provides certain measure of INDEPENDENCE to the trial and enhances the validity of trial results to be unencumbered by CONFLICT of interest.

A CRO or Clinical Research Organization is that which is contracted by the sponsor to conduct and monitor the trial. It provides certain measure of independence to the trial and enhances the validity of trial results to be unencumbered by conflict of interest.

The sponsor is the organization or individual that initiates the Ct and finances the study. The organization COULD be a government department, PHARMACEUTICAL COMPANY, UNIVERSITY or individual. It is normally a pharmaceutical company.

The sponsor is the organization or individual that initiates the Ct and finances the study. The organization could be a government department, pharmaceutical company, university or individual. It is normally a pharmaceutical company.

According to the ICH GCP, the following INFORMATION is to be INCLUDED in a protocol:

1. Protocol title 
2. Name and address of Sponsor and MONITOR
3. Name of authorized person
4. Name of Sponsor’s medical expert
5. Name of Investigator responsible for the trial
6. Name of PHYSICIAN responsible for trial - related medical decisions
7. Name of clinical laboratory and other institutions involved in the trial
8. Name and DESCRIPTION of the clinical trial protocol
9. Summary of results from nonclinical studies
10. Potential risks and benefits to human subjects
11. Description and justification for route of administration, dosage, and treatment plan
12. Compliance to GCP
13. Description of the population to be studied
14. Reference literature and related data
15. Standard operating procedures

According to the ICH GCP, the following information is to be included in a protocol:

IRB/IEC MAY consist of clinicians, scientists, lawyers, religious LEADERS, and LAY PEOPLE to represent different view points and protect the rights of the subjects.

IRB/IEC may consist of clinicians, scientists, lawyers, religious leaders, and lay people to represent different view points and protect the rights of the subjects.

IRB/IEC (Institutional Review Board/Independent Ethics COMMITTEE) ACTS as a third party to oversee the welfare of the TRIAL subjects and to ENSURE that the trial is being conducted in accordance with the SUBMITTED protocol.

IRB/IEC (Institutional Review Board/Independent Ethics Committee) acts as a third party to oversee the welfare of the trial subjects and to ensure that the trial is being conducted in accordance with the submitted protocol.

• Scope 
• Definitions
• Applicability to studies performed under grants and CONTRACTS
• Inspection of a testing facility
• Personnel
• Testing facility management
• Study director
• Quality assurance unit
• General
• Animal care facilities
• Facilities for HANDLING test and control articles
• LABORATORY operation areas
• Specimen and data storage facilities
• Equipment design
• Maintenance and calibration of equipment
• Standard operating procedures
• Reagents and solutions
• Animal care
• Test and control article characterization
• Test and control article handling
• Mixtures of articles with carriers
• Protocol
• Conduct of a non-clinical laboratory study
• Reporting of non-clinical laboratory study results
• Storage and retrieval of records and data
• Retention of records 
• Purpose
• Grounds for disqualification
• Notice of and opportunity for HEARING on proposed disqualification
• Final order on disqualification
• Actions upon disqualification
• Public disclosure of information regarding disqualification
• Alternative or additional actions to disqualification
• Suspension or TERMINATION of a testing facility by a sponsor
• Reinstatement of a disqualified testing facility.

A patent is the RIGHT granted by a government for any device, substance, or PROCESS that is new, inventive, and useful. The patent discloses the knowhow for the INVENTION and in return, the owner of the patent receives a 20 year period of MONOPOLY rights to commercially exploit the invention.

A patent is the right granted by a government for any device, substance, or process that is new, inventive, and useful. The patent discloses the knowhow for the invention and in return, the owner of the patent receives a 20 year period of monopoly rights to commercially exploit the invention.

FDA Definition of a drug:

An active ingredient that is intended to furnish pharmacological ACTIVITY or other direct effect in the diagnosis, CURE, mitigation, treatment, or prevention of a disease, or to affect the structure of any function of the human body,but does not include intermediates used in the synthesis of such ingredient.

More generic definition:

A drug is substance which provides favorable therapeutic or prophylactic pharmaceutical benefits to the human body

FDA Definition of a drug:

An active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of a disease, or to affect the structure of any function of the human body,but does not include intermediates used in the synthesis of such ingredient.

More generic definition:

A drug is substance which provides favorable therapeutic or prophylactic pharmaceutical benefits to the human body

ADHERENCE to all REGULATORY REQUIREMENTS.

Adherence to all regulatory requirements.

The PHYSICAL and MENTAL INTEGRITY of the SUBJECT.

The physical and mental integrity of the subject.

• Persons who cannot EXPRESS WILLINGNESS to volunteer 
• Persons influenced by EXPECTATIONS
• Persons with incurable diseases
• Persons who are unemployed, who BELONG to ethnic MINORITIES, who are homeless, minors andthose who can’t give consent and emergency patients.

RECORDS of ORIGINAL OBSERVATIONS.

Records of original observations.

FREEDOM from HARM.

Freedom from harm.

The probable HARM or DISCOMFORT CAUSED to the trial subject.

The probable harm or discomfort caused to the trial subject.

UNEXPECTED ADVERSE Drug Reaction. Which is an ADR not DOCUMENTED in a PROTOCOL or IB.

Unexpected Adverse Drug Reaction. Which is an ADR not documented in a protocol or IB.

Adverse EVENT Reporting System.Is used to KEEP track of the adverse events that MAY occur after a drug is marketed. It could be part of phase IV clinical trials.

Adverse Event Reporting System.Is used to keep track of the adverse events that may occur after a drug is marketed. It could be part of phase IV clinical trials.

SOURCE Data VERIFICATION and it is REQUIRED during AUDIT trails, discrepancy management.

Source Data Verification and it is required during audit trails, discrepancy management.

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210 and 211

210 and 211

Paper based Clinical Trials are CUMBERSOME, error prone, INFLEXIBLE, extensive takes a lot of time. ARCHIVAL of DATA is difficult. Electronic trials ADDRESS all these problems to either eliminate them or to minimize them

Paper based Clinical Trials are cumbersome, error prone, inflexible, extensive takes a lot of time. Archival of data is difficult. Electronic trials address all these problems to either eliminate them or to minimize them

• ANALYSIS DATA SETS
• Tabulation data sets
• PATIENT profiles
• LISTING datasets

Case Report TABULATION Data Definition SPECIFICATIONS; also known as define .xml, is a standard for providing data definition for case report tabulation in an xml format for submission to FDA. XML is platform NEUTRAL and faster to PROCESS.

Case Report Tabulation Data Definition Specifications; also known as define .xml, is a standard for providing data definition for case report tabulation in an xml format for submission to FDA. XML is platform neutral and faster to process.

lab standards define the EXCHANGE of laboratory DATA between the lab and CRO.

lab standards define the exchange of laboratory data between the lab and CRO.

1. ODM stands for Operational DATA Model.
2. It defines standards for the storage, archival and exchange of clinical TRIAL data
3. ODM is vendor and platform independent
4. ODM includes metadata associated with clinical data, administration data, reference data and audit trails
5. All information that needs to be shared among different Software systems during SETUP, operation ANALYSIS, submission and long term retention of data
6. ODM utilizes xml TECHNOLOGY

PROTOCOL STANDARDS

Protocol Standards

ODM: Operational Data MODEL. Standards for data storage formats.

SDTM: Study Data Tabulation Model

CRT-DDS: Case Report Tabulation Data Definition Specification

LAB standards: ADaM: Analysis Data Model

Protocol Standards:

SEND: Standards for exchange of Non-clinical data

ODM: Operational Data Model. Standards for data storage formats.

SDTM: Study Data Tabulation Model

CRT-DDS: Case Report Tabulation Data Definition Specification

Lab standards: ADaM: Analysis Data Model

Protocol Standards:

SEND: Standards for exchange of Non-clinical data

To standardize CLINICAL DATA To bring uniformity and vendor neutrality in clinical data To bring ease and cost effectiveness into data exchangeEasier submission and faster EVALUATION of CDISC compliant data by the regulatory bodies.

To standardize clinical data To bring uniformity and vendor neutrality in clinical data To bring ease and cost effectiveness into data exchangeEasier submission and faster evaluation of CDISC compliant data by the regulatory bodies.

To help in STREAMLINING the Clinical data LIFECYCLE by leveraging emerging industry data standards with strong DOMAIN and technological expertise. This in turn, HELPS the sponsor towards production of REGULATORY grade products throughout all stages of the Clinical Data Lifecycle.

To help in streamlining the Clinical data lifecycle by leveraging emerging industry data standards with strong domain and technological expertise. This in turn, helps the sponsor towards production of regulatory grade products throughout all stages of the Clinical Data Lifecycle.

clean data MEANS the data is ABLE to support the statistical analysis, and its subsequent Presentation and INTERPRETATION, as if the data is error FREE.

clean data means the data is able to support the statistical analysis, and its subsequent Presentation and interpretation, as if the data is error free.

ASCII STANDS for AMERICAN Standard Code for Information Interchange. ASII files are PLAIN text files which can be edited using any simple text EDITOR like notepad.

ASCII stands for American Standard Code for Information Interchange. ASII files are plain text files which can be edited using any simple text editor like notepad.

• Laboratory and PK/PD data
• Device data (ECG, flowmetry, vital signs, images ETC)
• ELECTRONIC PATIENT DIARIES

1. Protocol review and approval by an INSTITUTIONAL Review Board (IRB)
2. Right to INFORMED consent
3. Right of the subject to WITHDRAW consent
4. Right to notice of DISCLOSURE 
5. Confidential collection and submission of data

1. Data managers
2. Data processors
3. Statisticians
4. Site PERSONNEL
5. Clinical professionals
6. Compliance AUDITORS
7. Regulatory AFFAIRS personnel
8. All clinical research professionals making decisions regarding or using the clinical trial data

VERSION 4

Version 4

1. Committed to FOLLOWING the laws and guidelines applicable to clinical research (including the Declaration of Helsinki), to participate in the protection of the safety, dignity and well being of patients and to maintain the confidentiality of medical records.
2. Committed to creating, maintaining and presenting quality clinical data, thus supporting accurate and timely statistical analysis, and to adhering to applicable standards of quality and truthfulness in scientific research
3. Committed to facilitating communication between clinical data management professionals and all other clinical research professionals, to maintaining competency in all areas of clinical data management, to keeping current with technological advances, and to ensuring the DISSEMINATION of information to members of the clinical research team.
4. Committed to working as an integral member of a clinical research team with honesty, integrity and RESPECT. To making and communicating accountability for clinical data management decisions and actions within the clinical trial process. 
5. Committed to maintaining and respecting proprietary KNOWLEDGE at all levels, to avoiding the use of proprietary knowledge for personal gain, and to disclosing any conflict of interest. To avoiding any conduct or behavior that is unlawful, unethical or that may otherwise reflect negatively on the profession of clinical data management
6. Committed to advancing the profession of clinical data management through the development, distribution and improvement of good clinical data management practices. To AIDING the professional development and advancement of colleagues within the clinical trial industry.

SIGNATURE MANIFESTATION

Signature manifestation

CLOSED system MEANS an environment in which system access is controlled by persons who are RESPONSIBLE for the content of ELECTRONIC records that are on the system.

Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.

Electronic SIGNATURE means a COMPUTER data compilation of any symbol or series of SYMBOLS executed, ADOPTED, or authorized by an INDIVIDUAL to be the legally binding equivalent of the individual’s handwritten signature.

Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.

Act MEANS the FEDERAL Food DRUG and Cosmetics Act ((SEC. 201-903) (21U.S.C 321-393) )

Act means the Federal Food Drug and Cosmetics Act ((sec. 201-903) (21U.S.C 321-393) )

SECTION 11.2 of 21 CFR PART 11 describes the IMPLEMENTATION.

Section 11.2 of 21 CFR Part 11 describes the Implementation.

Electronic Records (11.10 to 11.70)

11.10 Controls for closed SYSTEMS.

11.30 Controls for open systems.

11.50 SIGNATURE MANIFESTATIONS.

11.70 Signature/record LINKING

Electronic Records (11.10 to 11.70)

11.10 Controls for closed systems.

11.30 Controls for open systems.

11.50 Signature manifestations.

11.70 Signature/record linking

ELECTRONIC RECORDS and Electronic SIGNATURES.

Electronic Records and Electronic signatures.

1. Criteria under which electronic records and signatures are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.
2. part APPLIES to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in AGENCY regulations. This part ALSO applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part
3. Does not apply to paper records that are, or have been, transmitted by electronic means.
4. Electronic records that meet the requirements of this part may be used in lieu of paper records, in accordance with § 11.2, UNLESS paper records are specifically required.
5. Computer systems (including HARDWARE and software), controls, and attendant documentation maintained under this part shall bereadily available for, and subject to, FDA inspection

Remote DATA CAPTURE. RDC involves the data ENTRY through networked systems like INTERNET.

Remote Data Capture. RDC involves the data entry through networked systems like internet.

The process of collection of DATA into a persistent form. This includes data entry (keyboard EDC, voice recognition, pen-based SYSTEMS) and automated(or DIRECT) data acquisition(BAR code SCANNERS, blood pressure cuff devices etc)

The process of collection of data into a persistent form. This includes data entry (keyboard EDC, voice recognition, pen-based systems) and automated(or direct) data acquisition(bar code scanners, blood pressure cuff devices etc)

As a result of batch validation, the discrepancies that arise in the database are managed by the discrepancy MANAGEMENT team.

1. Discrepancies are resolved through the Data Clarification Form (DCF) or the Data Query Form (DQF).
2. DCF is generated and SENT to the site (investigator) for clarification.
3. After the corrected VALUES are received from the investigator as a response to the DCF, the responses are updated in the database.
4. After ensuring that the data is error free, the database is locked to AVOID further unauthorized Modifications.

As a result of batch validation, the discrepancies that arise in the database are managed by the discrepancy management team.

SAS 9.0 ENVIRONMENT

SAS 9.0 environment

When a DATABASE is CLOSED, no further modifications are ALLOWED on the database. The PERMISSION to further MODIFY the data rests with a privileged few, most critical study personnel.

When a database is closed, no further modifications are allowed on the database. The permission to further modify the data rests with a privileged few, most critical study personnel.

DIGITIZATION is the PROCESS of CONVERTING the DATA into computer readable format.

digitization is the process of converting the data into computer readable format.