All relevant safety information contained in the company core data sheet (CCDS) prepared by the marketing authorization / licence holder and which the MA holder requires to be listed in all countries where the company markets the drug, except when the local regulatory authority specifically requires a modification
The CCSI is the reference information by which listed and unlisted are determined for the purpose of periodic reporting for marketed products, but not by which expected and unexpected are determined for expedited reporting.
For the purpose of periodic Safety Update Report, the CCSI forms the basis for determining whether an ADR is already listed or is still unlisted.
For a clinical trial, the CCSI is the company core data sheet, prepared by the MAH of a marketed product when it is used as an investigational medicinal product, except when the local regulatory authority specifically requires a modification. For investigational products the CCSI is the Development Core Safety Information.
Tuesday, September 21, 2010
Company Core Data Sheet(CCDS)
A document prepared by the marketing authorization holder containing, in addition to safety information, material relating to indications, dosing, pharmacology and other information concerning the product.
The CCDS is required to judge whether an adverse event or adverse drug reaction is labeled / listed or unlabelled / unlisted and is therefore always included in a periodic safety update report (PSUR).
In many countries involved in the international conference on harmonization (ICH) as members or observers, this kind of document is similar to the labelling approved as part of the marketing authorisation, although there are often differences because of differences in the scope of the document, principles for inclusion, indications and / or recommended dosage of the drug, experience drawn from pre-registration studies and from the market, local habits for concomitant drugs and local or ethnic sensitivity. The classification ‘labeled’ or ‘unlabelled’ has many more consequences for expedited reporting than for periodic reporting. The CCDS must be dated, including the date of last revision (or all revision dates).
CCDS are usually prepared by an applicant for a drug substance (active ingredient) rather than a drug product because post-marketing PSUR’s and IPSR’s would be based on a drug substance.
The CCDS is required to judge whether an adverse event or adverse drug reaction is labeled / listed or unlabelled / unlisted and is therefore always included in a periodic safety update report (PSUR).
In many countries involved in the international conference on harmonization (ICH) as members or observers, this kind of document is similar to the labelling approved as part of the marketing authorisation, although there are often differences because of differences in the scope of the document, principles for inclusion, indications and / or recommended dosage of the drug, experience drawn from pre-registration studies and from the market, local habits for concomitant drugs and local or ethnic sensitivity. The classification ‘labeled’ or ‘unlabelled’ has many more consequences for expedited reporting than for periodic reporting. The CCDS must be dated, including the date of last revision (or all revision dates).
CCDS are usually prepared by an applicant for a drug substance (active ingredient) rather than a drug product because post-marketing PSUR’s and IPSR’s would be based on a drug substance.
Investigator Brochure Update
An IB is usually revised and updated to include new information at least annually, if not more frequently, depending on the stage of development and the volume of new relevant information generated. If the clinical trial is not sponsored by the pharmaceutical company, but is sponsored by the investigator, the sponsor-investigator is responsible for obtaining any updates to the brochure from the commercial manufacturer and distributing the updates to the clinical sites. If the investigational product is provided by the sponsor-investigator, then he or she should provide the necessary information to the trial personnel. If a formal IB is impractical, the sponsor-investigator should provide an expanded background information section in the trial protocol as a substitute. This section must contain the minimum current information described in the ICH guideline.
The Principal Investigator conducting the study at each site is responsible for ensuring the current IB has been provided to the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) while the study is ongoing at their site. The IEC or IRB reviews the IB as part of its responsibilities in reviewing and approving the clinical trial protocol and the investigators conducting the study. New information may be so important that it should be communicated to the investigators, and possibly to the IRBs/IEBs before it is included in a revised IB.
When providing an updated IB to the IEC/IRB, it is common practice to provide a listing of the changes made between the previous and current version. It is often helpful to the study sites to provide the change history to help ensure the study staff are aware of the changes. It is important, therefore, to have a document control system in place to manage the editing and publishing process.
As part of the site management process for regulated studies, it is common practice to have the site sign and return a document indicating the updated IB has been received and reviewed. Documentation of IRB approval is also required to be maintained in the study files both at the study site and by the study sponsor.
The Principal Investigator conducting the study at each site is responsible for ensuring the current IB has been provided to the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) while the study is ongoing at their site. The IEC or IRB reviews the IB as part of its responsibilities in reviewing and approving the clinical trial protocol and the investigators conducting the study. New information may be so important that it should be communicated to the investigators, and possibly to the IRBs/IEBs before it is included in a revised IB.
When providing an updated IB to the IEC/IRB, it is common practice to provide a listing of the changes made between the previous and current version. It is often helpful to the study sites to provide the change history to help ensure the study staff are aware of the changes. It is important, therefore, to have a document control system in place to manage the editing and publishing process.
As part of the site management process for regulated studies, it is common practice to have the site sign and return a document indicating the updated IB has been received and reviewed. Documentation of IRB approval is also required to be maintained in the study files both at the study site and by the study sponsor.
MedDRA
MedDRA is used for coding medical terms generated during all phases of clinical trial, excluding animal toxicology,therapeutic indications which include signs, symptoms,diseases, diagnosis, or prophylaxis of disease, and modification of functions, coding names and quantitative results of investigations,surgical procedures and medical/social/family history.
MedDRA releases 2 versions in a year - one in March and the second in September. One can obtain access to the MedDRA terminology annually, by renewable subscription.Each subscription brings all MedDRA updates that incorporate approved changes and additions .
MedDRA has five hierarchical levels as listed below
Low Level Term (LLT),
Preferred Tem (PT),
High Level Term (HLT),
High Level Group Term (HLGT),
System Organ Class (SOC)
MedDRA releases 2 versions in a year - one in March and the second in September. One can obtain access to the MedDRA terminology annually, by renewable subscription.Each subscription brings all MedDRA updates that incorporate approved changes and additions .
MedDRA has five hierarchical levels as listed below
Low Level Term (LLT),
Preferred Tem (PT),
High Level Term (HLT),
High Level Group Term (HLGT),
System Organ Class (SOC)
Medical Coding in Clinical Trials
All data generated in Clinical trials are ultimately subjected to further analysis. It is very essential that this data gets interpreted uniformly in a standardized format.Medical coding is performed in clinical trial using Standardised medical coding dictionaries.Data listed above like AEs, SAEs, MH , CM and any other category generally are coded. However coding AEs, SAEs and CM is mandate in any given clinical trial.
There are several standardized medical coding dictionaries in the market; however five dictionaries listed below are used for coding:
1. COSTART - Coding Symbols for Thesaurus of Adverse Reaction Terms
2. ICD9CM - International Classification of Diseases 9 Revision Clinical Modification
3. MedDRA – Medical Dictionary for Regulatory Activities
4. WHO-ART – World Health Organisation Adverse Reactions Terminology
5. WHO-DDE– World Health Organisation Drug Dictionary Enhanced
Out of the above five, two widely used medical coding dictionaries used for coding medical terms generated in clinical trials are MedDRA and WHO-DDE.
There are several standardized medical coding dictionaries in the market; however five dictionaries listed below are used for coding:
1. COSTART - Coding Symbols for Thesaurus of Adverse Reaction Terms
2. ICD9CM - International Classification of Diseases 9 Revision Clinical Modification
3. MedDRA – Medical Dictionary for Regulatory Activities
4. WHO-ART – World Health Organisation Adverse Reactions Terminology
5. WHO-DDE– World Health Organisation Drug Dictionary Enhanced
Out of the above five, two widely used medical coding dictionaries used for coding medical terms generated in clinical trials are MedDRA and WHO-DDE.
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