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
Friday, October 1, 2010
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.
Case Report Form (CRF) - Clinical Trials
The ICH GCP Guidelines say: The reason for having CRFs in a study is to (collect the necessary information about:
When completing the form use a black ball point pen to complete the CRF. If the CRFs are printed on carbonless duplication paper, always make sure that a suitable separator is inserted under the form being completed. If for some reason you cannot complete part of the form, you shouldn’t just leave a blank space ~ this is impossible for the people doing the data entry into the computer to interpret. Instead write unknown, uncertain, missing or test not donr as appropriate, or similar unambiguous words. Avoid using the ambiguous phrase, ‘not available’.The CRFs must be signed where indicated by the Principal Investigator to indicate that
he/she believes they are complete and correct. Some Sponsors require a signature on each page of the CRF, some only a signature on the final page.
Ensure legibility of all data entries. Corrections should be made as follows:
- the patients
- the administration of the study drug
- the outcome of the assessments.
When completing the form use a black ball point pen to complete the CRF. If the CRFs are printed on carbonless duplication paper, always make sure that a suitable separator is inserted under the form being completed. If for some reason you cannot complete part of the form, you shouldn’t just leave a blank space ~ this is impossible for the people doing the data entry into the computer to interpret. Instead write unknown, uncertain, missing or test not donr as appropriate, or similar unambiguous words. Avoid using the ambiguous phrase, ‘not available’.The CRFs must be signed where indicated by the Principal Investigator to indicate that
he/she believes they are complete and correct. Some Sponsors require a signature on each page of the CRF, some only a signature on the final page.
Ensure legibility of all data entries. Corrections should be made as follows:
- Cross out the incorrect entry with a single line - the incorrect entry should still be readable, on no account use liquid correcting fluid.
- Enter the correct data.
- Initial and date the correction, and give an explanation of the correction if it is not obvious why it was changed.
Informed Consent form- Signature
The consent form should be signed and dated by the following people:
A witness is defined as someone who records that the subject has provided consent of their own free will and has been fully informed of the study. The best witness is a subject’s friend or family member who has sat in when the study was being explained to the patient. A witness must have no vested interest in the study; therefore a research assistant/SSC/Sub-Investigator is not suitable as a witness.All signatures should be dated by the person who is signing and under the signature or Sub-Investigator. they should write their name in block capitals.
- A medically qualified person providing the information, this being the Investigator
- The subject.
- A witness, if this is possible and if required for the study.
A witness is defined as someone who records that the subject has provided consent of their own free will and has been fully informed of the study. The best witness is a subject’s friend or family member who has sat in when the study was being explained to the patient. A witness must have no vested interest in the study; therefore a research assistant/SSC/Sub-Investigator is not suitable as a witness.All signatures should be dated by the person who is signing and under the signature or Sub-Investigator. they should write their name in block capitals.
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