Here u go with another useful link for all the Clinical Research Bloggers.
http://clinicalresearchbelt.blogspot.com/
Wednesday, November 3, 2010
Sunday, October 3, 2010
Clinical Study Reports- Medical Writing
Structure and Content of Clinical Study Reports ICH Topic E3:
Source: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/e3-eng.pdf
Source: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/e3-eng.pdf
Friday, October 1, 2010
Commonly used Medical Dictionaries during coding- Clinical Trials
The most commonly used medical coding dictionaries used for coding medical terms are MedDRA and WHO DDE.
The other standardised medical dictionaries are:
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
The other standardised medical dictionaries are:
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
Reporting to the Ethics Committee- Safety Reporting during Clinical trials
The Ethics Committee that gave a favourable opinion for the trial should routinely receive the following reports:
• Expedited reports of all SUSARs occurring in a clinical trial of an investigational medicinal product for which the sponsor is responsible. This includes SUSARs associated with active comparator drugs. Expedited reports should be sent to the relevant Ethics Committee within the timelines as stated below.
• A sponsor shall ensure that all relevant information about a suspected unexpected serious adverse reaction (SUSAR) which occurs during the course of a clinical trial in the United Kingdom and is fatal or life-threatening is reported as soon as possible to the MHRA, the competent authorities of any EEA State, other than the United Kingdom, in which the trial is being conducted, and the relevant Ethics Committee. This needs to be done not later than seven days after the sponsor was first aware of the reaction. Any additional relevant information should be sent within eight days of the report.
• A sponsor shall ensure that a suspected unexpected serious adverse reaction (SUSAR) which is not fatal or life-threatening is reported as soon as possible, and in any event not later that 15 days after the sponsor is first aware of the reaction.
• Quarterly safety reports on all clinical trials for which the sponsor is responsible for worldwide, with a global line listing of SUSARs occurring in these trials in the reporting period.
• Annual safety reports on the safety of subjects in all clinical trials for which the sponsor is responsible worldwide, with an aggregated global line listing of all suspected serious adverse reactions (SSARs) occurring in these trials to date.
• Reports and recommendations of any independent data monitoring committee established for the trial.
Safety reports may be submitted by the sponsor, or by the sponsor’s representative, or by the chief investigator.
• Expedited reports of all SUSARs occurring in a clinical trial of an investigational medicinal product for which the sponsor is responsible. This includes SUSARs associated with active comparator drugs. Expedited reports should be sent to the relevant Ethics Committee within the timelines as stated below.
• A sponsor shall ensure that all relevant information about a suspected unexpected serious adverse reaction (SUSAR) which occurs during the course of a clinical trial in the United Kingdom and is fatal or life-threatening is reported as soon as possible to the MHRA, the competent authorities of any EEA State, other than the United Kingdom, in which the trial is being conducted, and the relevant Ethics Committee. This needs to be done not later than seven days after the sponsor was first aware of the reaction. Any additional relevant information should be sent within eight days of the report.
• A sponsor shall ensure that a suspected unexpected serious adverse reaction (SUSAR) which is not fatal or life-threatening is reported as soon as possible, and in any event not later that 15 days after the sponsor is first aware of the reaction.
• Quarterly safety reports on all clinical trials for which the sponsor is responsible for worldwide, with a global line listing of SUSARs occurring in these trials in the reporting period.
• Annual safety reports on the safety of subjects in all clinical trials for which the sponsor is responsible worldwide, with an aggregated global line listing of all suspected serious adverse reactions (SSARs) occurring in these trials to date.
• Reports and recommendations of any independent data monitoring committee established for the trial.
Safety reports may be submitted by the sponsor, or by the sponsor’s representative, or by the chief investigator.
Subscribe to:
Posts (Atom)