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safety database
|
A database typically used by Drug Safety or Pharmacovigilence departments to collect adverse event data.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
Is life-threatening;
|
Requires hospitalization or prolongs hospitalization of a subject; Results in persistent or significant disability/incapacity; or Is a congenital anomaly/birth defect. Service Level Agreement (SLA) - from the Vendor chapter An SLA is part of a service contract where the level of service is formally defined.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
source data
|
All information that is necessary for the reconstruction and evaluation of the trial, including information about clinical findings, observations, or other activities in a clinical trial. Source data are contained in source documents such as original records or certified copies of original records.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
source documents
|
Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial).
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
special causes
|
(ASQ) Causes of variation that arise because of special circumstances. These causes are not an inherent part of a process. Special causes are also referred to as assignable causes. See also common causes.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
specification
|
(ASQ) A document that states the requirements to which a given product or service must conform.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
sponsor
|
An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. See also MRCT Center Clinical Research Glossary definition.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
sponsor-investigator
|
An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). A sponsor-investigator must fulfill the obligations of both a sponsor and an investigator.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
standard operating procedures (SOPs)
|
Detailed instructions written to achieve uniformity of the performance of a specific function.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
statistical process control (SPC)
|
(ASQ) The application of statistical techniques to control a process. Often the term “statistical quality control” is used interchangeably with “statistical process control.”
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
statistical quality control (SQC)
|
(ASQ) The application of statistical techniques to control quality. Often the term “statistical process control” is used interchangeably with “statistical quality control,” although statistical quality control includes acceptance sampling as well as statistical process control.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
sub-investigator
|
Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). See also investigator.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
subject/trial subject
|
An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control. See also MRCT Center Clinical Research Glossary definition.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
subject identification code
|
A unique identifier assigned by the investigator to each trial subject to protect the subject’s identity and to be used in lieu of the subject’s name when the investigator reports adverse events and/or other trial related data.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
trial site
|
The location(s) where trial-related activities are actually conducted.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
trigger
|
An event that precipitates other events.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
Type I error
|
(ASQ) An incorrect decision to reject something that is acceptable, such as a statistical hypothesis or a lot of products.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
Type II error
|
(ASQ) An incorrect decision to accept something that is unacceptable.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
unexpected adverse drug reaction
|
An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., investigator’s brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product). See the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
vulnerable subjects
|
Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include subjects with incurable diseases, persons in nursing homes, unemployed or impoverished persons, subjects in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
well-being (of the trial subjects)
|
The physical and mental integrity of the subjects participating in a clinical trial.
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
WHOdrug
|
WHO Drug is a dictionary of medicinal product information. It is used to identify drug names and provides information about a drug's active ingredients and its therapeutic use(s).
|
[
"GCDMP_Glossary.pdf"
] |
GCDMP_Glossary.pdf
|
pdf
|
glossary.json
| null | null |
The aims of the programme are:
|
a. To verify GCP compliance to protect the rights, safety and well being of
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
|
glossary.json
| null | null |
the subjects involved in clinical trial
|
b. To verify the credibility and integrity of clinical trial data generated c. To verify the compliance with various regulatory provisions as per
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
|
glossary.json
| null | null |
Drugs & Cosmetics Rules
|
The purpose of this programme is to provide direction to inspectors/CDSCO officers for conducting inspection of site of clinical trial, sponsor / CRO’s facilities involved in clinical trial and information to investigators, sponsor/ CRO’S about procedures for inspection and follow up of action. 3
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
|
glossary.json
| null | null |
Scope and extent of the programme:
|
Clinical trial inspection programme covers all clinical trial sites and sponsor / CRO’s facilities involved in clinical trial of drugs including biological and medical device covered under Drugs & Cosmetics Act.
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
|
glossary.json
| null | null |
Planning for Inspection:
|
Inspection can be conducted before, during or after a clinical trial is completed. 4.1
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
|
glossary.json
| null | null |
Selection of studies:
|
Inspection can be carried out as a routine surveillance or for any specific cause(s).Study may be selected for inspection based on, but not restricted to the following criteria: 4.1.1
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
|
glossary.json
| null | null |
Nature of study
|
4.1.2 For regulatory decision based on clinical trial data 4.1.3
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
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glossary.json
| null | null |
Vulnerability of subjects
|
4.1.6 Number of CT including number of subject enrolled at a
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
|
glossary.json
| null | null |
Inspection assignments:
|
CDSCO HQ will issue instruction to the CDSCO Officers /Inspectors to conduct the inspection identifying the Clinical trial, name, address, contact number of clinical trial site, sponsor / CRO’s facilities to be inspected. It may also identify the type and purpose of the inspection and provide background materials like study protocol, CRF etc. 4.3
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
|
glossary.json
| null | null |
Preparing for inspection:
|
The inspector shall go through the information provided by CDSCO HQ and develop a plan for conducting the inspection.
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
|
glossary.json
| null | null |
Scheduling the inspection:
|
Inspection of clinical trial site would generally be pre-announced to ensure availability of the Investigator / SubInvestigator and other personnel along with study records at the time of the inspection. The date of inspection and other arrangements would be finalised by the CDSCO Officers / Inspector(s) in coordination with the investigator /sponsor/ CRO. Under some specific circumstances unannounced inspection of clinical trial sites can be carried out as per the direction of CDSCO HQ. Inspection of CRO/Sponsor can be conducted without prior notice. 5.
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
|
glossary.json
| null | null |
Conducting the inspection:
|
5.1 Clinical Trial Sites: The inspection includes verification of essential documents to determine whether the trial related activities were in accordance with the protocol, GCP guidelines published by DGHS, Govt. of India and Schedule Y as well as other applicable regulatory requirements. When inspection is carried out after completion of the clinical trial, it will include comparison of data generated by the sponsor with source documents at the clinical trial sites and Case Record Form (CRF) in the investigator’s files. If it is a routine surveillance or “for cause” inspection of an ongoing clinical trial, the comparison will generally include source documents and CRF. 5.1.1 Opening interview: Inspector should meet investigator / key person of Sponsor and present his / her identity card. The inspector should provide verbal summary of methods and procedures to be followed during the inspection.
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
|
glossary.json
| null | null |
out:
|
5.1.1.1 Investigator prior education and GCP experience, GCP training provided by the sponsor. 5.1.1.2 Who did what, when, where and how with respect to
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
|
glossary.json
| null | null |
product,
|
Collection and analysing of data, Recording, transcribing and reporting of data to sponsor, Archiving the data 5.1.1.3 How did the investigator identify the subjects for the study, 5.1.1.4 Date of enrolment first and last subject 5.1.1.5 About Ethics Committee the site is using 5.1.1.6 Whether the investigator has copies of protocol, permission from CDSCO, undertaking by the investigator etc. 5.1.1.7 Information about unexpected and serious adverse events (if any) occurred at the site, 5.1.1.8 Information about monitoring/auditing of the site by sponsor/CRO. During the interview other relevant facts may also be found out. 5.1.2 ORGANIZATION & DELEGATION OF RESPONSIBILITIES:
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
|
glossary.json
| null | null |
Inspector shall verify / obtain following:
|
5.1.2.1 Brief about study site. 5.1.2.2 Status of the study. 5.1.2.3 Whether investigator has agreement with sponsor for the study. 5.1.2.4
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
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glossary.json
| null | null |
Whether financial & Confidentiality agreement with
|
Investigator and concerned laboratory (ies) in place. 5.1.2.5
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
|
glossary.json
| null | null |
In Investigator undertaking protocol title, Investigator’s
|
name, address, telephone no of site, qualification, Name & address of laboratories, Name of Sub-Investigator etc are in-compliance with Schedule Y of Drugs & Cosmetics Rules 1945.
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
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glossary.json
| null | null |
Page 8 of 17
|
5.1.2.6 Obtain list of all clinical trials performed by investigator. The list should have information such as Protocol Number Protocol Title Name of Sponsor/CRO Study date 5.1.2.7
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
|
glossary.json
| null | null |
Determine whether authority for conducting various
|
Clinical trial related activities were delegated properly by the Investigator to the competent personnel so that investigator was able to supervise the study adequately. Obtain a list of personnel with delegated activity. 5.1.2.8
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
|
glossary.json
| null | null |
Documents following;
|
Date of EC / IEC approval including initial review of protocol, amendment, ICD etc. Date of screening of first subject, Date of signing ICF by the first subject Date of first administration of IP, Date of last follow up of any subject, 5.1.2.9 List the name and address of facilities involved in laboratory test required by protocol. Verify accreditation status and adequacy of these facilities to perform the
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
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pdf
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glossary.json
| null | null |
specified test,
|
5.1.2.10 Obtain a copy of site enrolment log, 5.1.2.11 Determine whether SOP’s for various activity are
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
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glossary.json
| null | null |
established and documented,
|
5.1.3 Study Protocol 5.1.3.1 Determine if, there are any difference between protocol provided to CDSCO and the protocol in the Investigator’s
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
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glossary.json
| null | null |
approved
|
Version number and EC approval of amendments 5.1.4 Subject record & Informed consent: 5.1.4.1 Review the Informed Consent Form (ICF) signed by the subjects. If the number of subjects at site is relatively small (e.g.20or less) 100% of the ICF can be reviewed.
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
|
glossary.json
| null | null |
Determine the following:
|
5.1.4.2 whether ICF have all the elements enlisted in Appendix V
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
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glossary.json
| null | null |
of Schedule Y,
|
5.1.4.3 whether IC has been obtained from each subjects prior to participation of the subject in the study, 5.1.4.4 whether signature/thumb impression of the subjects have
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
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pdf
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glossary.json
| null | null |
been affixed with date,
|
5.1.4.5 whether in case of illiterate subjects or illiterate representative of a subject, there are signature and details
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
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glossary.json
| null | null |
Have patient signature been personally dated?
|
5.1.4.8 Has the dated signature of the designated person for
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
|
pdf
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glossary.json
| null | null |
administering informed consent (IC) been affixed?
|
5.1.4.9 Is the designated person for administering IC medically
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
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pdf
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glossary.json
| null | null |
qualified?
|
5.1.4.10 If IC has been administered by a designated person who is not medically qualified, is there evidence that subject's queries of a medical nature were answered by a medically
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
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glossary.json
| null | null |
qualified person or the investigator?
|
5.1.4.11 Is the completed ICF signed and dated by the
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
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pdf
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glossary.json
| null | null |
investigator?
|
5.1.5 Source Documents and Case Record Form 5.1.5.1
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
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pdf
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glossary.json
| null | null |
Verify condition, completeness, legibility, accessibility of
|
the investigators source data file. 5.1.5.2 Determine whether subjects who were enrolled and /or completed the study meet inclusion and exclusion criteria; 5.1.5.3 Determine whether subject received the test drug with respect to dose and frequency specified according to the
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
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glossary.json
| null | null |
Page 10 of 17
|
5.1.5.4 Determine whether safety/ efficacy end point data was collected and reported in accordance with the protocol; 5.1.5.5 Does medical record mentions subject ID/ name /hospital registration number / and indication that subjects are
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
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glossary.json
| null | null |
participating in a clinical trial
|
5.1.5.6 Whether all adverse events were reported in CRF; 5.1.5.7 Compare the source document with CRF and determine whether source data have been correctly transcribed in
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
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glossary.json
| null | null |
CRF;
|
5.1.5.8 Verify whether all SAE’s have been reported to the sponsor (within 24 hours) and EC (within 7 working
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
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| null | null |
days);
|
5.1.5.9 Verify whether adequate medical care have been given to the subject especially in the event of inter current illness,
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
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glossary.json
| null | null |
adverse events including abnormal lab parameters;
|
5.1.6 Ethics Committee (EC) / Independent Ethics
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
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pdf
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glossary.json
| null | null |
Committee (IEC):
|
5.1.6.1 Identify the name , address of the EC/ IEC in the approval letter and compare it with that stated in investigators
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
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pdf
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glossary.json
| null | null |
undertaking ;
|
5.1.6.2 Verify if IEC approval letter mention study code , Protocol title and version number of the protocol, list of other documents reviewed, list of members present at the meeting, quorum of five members as specified in Schedule Y satisfied, date, time , venue of the meeting, signature and date of member secretary / Chairman; 5.1.6.3 In case the site does not have an IEC, verify whether
|
[
"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
] |
Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf
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pdf
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glossary.json
| null | null |
Verify/ determine:
|
5.1.7.1 Whether a clinical trial Investigators agreement has been signed for this study with the sponsor; 5.1.7.2 Whether investigator maintains copies of all reports
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submitted to the sponsor;
|
5.1.7.3 Whether all SAE are reported to sponsor within 24 hours; 5.1.7.4 Whether all CRFs were submitted to sponsor after
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completion of study;
|
5.1.7.5 Whether all dropouts and reasons thereof were reported
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to sponsor;
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5.1.7.6 The method and frequency of monitoring the progress of
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the study by the sponsor;
|
5.1.7.7 Whether a log of onsite monitoring visit is maintained at
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the site;
|
5.1.8 Test Drug Accountability: 5.1.8.1 Review individual subject record to verify the correct dose administration with respect to dose, frequency, route of
|
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administered/dispensed the test drug
|
5.1.8.3 Determine whether adequate record of qty. of test drug received , dispensed/ destroyed/returned is maintained ; 5.1.8.4
|
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are as per protocol/recommendation;
|
5.1.8.5 Whether trial medication are maintained under controlled
|
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access;
|
5.1.8.6 Have un-used trial medications been returned to the sponsor or disposed of according to protocol? In case of destruction at site, is there a certificate of destruction on
|
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file?
|
5.1.8.7 Are the drugs dispensing records being maintained
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properly?
|
5.1.8.8 Are the records for reconciliation of all IPs received from
|
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Page 12 of 17
|
5.1.9 Record retention: 5.1.9.1 Is adequate space available at the site for retention of
|
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destruction;
|
5.1.9.3 Determine who maintained custody of the documents and
|
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means for assuring prompt action;
|
5.1.10 Concluding the Inspection: The inspector should conclude the inspection with final discussion with the Investigator. During discussion the inspector should explain inspection finding .The inspector may also issue a list of observation at the conclusion of inspection. 5.2 Inspection of CRO/Sponsor The inspection includes verification of essential documents to compare practice and procedure followed by the CRO/Sponsor to that committed in the clinical trial application and GCP guidelines published by DGHS, Govt. of India and Schedule-Y as well as other applicable regulatory requirements. Inspection of CRO/Sponsor can be conducted without prior notice. During inspection following aspects may be verified. 5.2.1 Documents submitted to CDSCO and regulatory approvals obtained. 5.2.1.1 Clinical Trial application and DCGI approval letter 5.2.1.2 Import license application(Form 12) and import licence obtained (Form 11)Copy of license in Form 29 from (State Licencing Authority) SLA (in case of manufacture
|
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List of investigators
|
5.2.1.5 Investigator Undertaking (as per Appendix VII of
|
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Page 13 of 17
|
5.2.1.8 Patient Information Sheet and Informed Consent Form 5.2.1.9
|
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Case Record Form
|
5.2.1.10 Ethics Committee approval and notifications to CDSCO 5.2.1.11
|
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Study report
|
5.2.2 Organisation and personnel: 5.2.2.1
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Company profile and overall structure,
|
5.2.2.2 Organization chart for management of the clinical trial, Structure and responsibilities for all activities involving
|
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Statistical Analysis, Electronic Records/Clinical Database,
|
Clinical Supplies-Investigational Products (IP) Archival. 5.2.2.3 Identify and determine the personnel responsible for
|
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qualifications
|
Job description of key stake holders Verify clinical personnel training record To obtain a list of external service providers and contractors and documentation of the service they provide. Verify
|
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various
|
responsibilities and clinical trial related activities.
|
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Page 14 of 17
|
5.2.3 Selection and monitoring of investigators 5.2.3.1 Obtain list of all investigators along with Investigator
|
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Criteria for selection of sites
|
5.2.3.3 Information provided to sites viz.
|
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previous trials, Investigator's Brochure, Product labelling,
|
Training, All versions and updates etc. 5.2.3.4
|
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Investigator’s non-compliance (If any)
|
Deviations from CDSCO regulations Deviations form protocol How sponsor handles serious deviations from approved protocol or Schedule Y /Indian GCP Guidelines. 5.2.3.5
|
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Selection of monitor:
|
List all monitors for study duration Selection criteria for monitors Job descriptions/responsibilities Qualifications Training Records and CVs Reporting structure Monitoring SOP Frequency, scope and process, Obtain a copy of SOP and check compliance, If no SOPs, interview monitors to check how monitoring was done , Monitoring Plan, Monitoring Reports 5.2.3.7 Review the Pre trial and periodic trial visit report in respect
|
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etc Validity/Completeness
|
Informed Consents, Confirmation of consent and process of consent. Use of IEC approved forms. Adequacy of consent documentation,
|
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"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
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Page 15 of 17
|
Which CRFs were compared to source docs? When and who verified CRFs against source data (hospital records, office charts, laboratory reports, etc.) at the study site. Form for data verification Check copy of any SOPs and guidelines for data
|
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verification
|
Data correction handling, Compliance to Monitoring Plan, Frequency, Follow up etc. 5.2.4 Quality Assurance (QA): 5.2.4.1 Verify SOP for QA audits and operation of quality
|
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"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
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assurance unit
|
5.2.4.2 Describe how the audit and monitoring are separated 5.2.4.3
|
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Obtain list of audited trial
|
5.2.5 Adverse events reporting: 5.2.5.1 Verify sponsor’s method for following up of adverse events and for dissemination of AE information to others
|
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"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
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Investigators:
|
5.2.5.2 Obtain list of SAE reported, Including death 5.2.5.3 Verify the timeline for reporting the SAE to CDSCO and
|
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"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
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other Investigators /EC;
|
5.2.6 Data collection and handling 5.2.6.1 Study tabulations: List of all studies for marketing
|
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"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
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Authorization
|
5.2.6.2 Data Tabulations: Number of subjects. Verify if number in
|
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"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
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| null | null |
application(compare to CRFs submitted)
|
5.2.6.3 If any subjects not included in the marketing Authorization
|
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| null | null |
application? Why not included?
|
5.2.6.4 Review of SOPS to verify compliance to assure the integrity of safety and efficacy data collected from clinical
|
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"Guidelines_On_Clinical_Trial_Inspection-DCGI_11-2-2011.pdf"
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| null | null |
investigators
|
5.2.6.5 Verify that the SOPs were followed and document any
|
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Statistical processes
|
5.2.6.8 Primary endpoints Compare the tabulations with CRFs
|
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