of a product (i.e., a pill, a solution, etc.) Ambiguous Information (see also MTS:PTC Section 3.4.2): Reported LLT Selected Comment It is not what medical condition the patient had Patient had medical history Ill-defined disorder (aortic regurgitation, arterial of AR restenosis, allergic rhinitis?), so LLT Ill-defined disorder can be selected Conflicting Information (See also MTS:PTC Section 3.4.1): Reported LLT Selected Comment LLT Haemoglobin abnormal covers both of Severe anaemia with a Haemoglobin abnormal the reported concepts haemoglobin of 19.1 g/dL (note: haemoglobin value of 19.2 g/dL is a high result, not a low result as would be expected in severe anaemia Training Appropriate ongoing training is a key part of a good data quality strategy. Training should be to all persons involved in the collection, transcription, categorisation, entry, coding, and review of information. Organisational training practices and procedures should be documented in writing and continually reviewed for updates. Training should be performed by appropriately qualified individuals who are knowledgeable about the organisation’s standardised procedures and focused on compliance. Cross-training of key functions is advisable to ensure a consistent approach and to preserve data quality standards during periods of unexpected personnel changes. that organisations may commonly use unfamiliar or remote study sites for clinical trial conduct, it is also important to ensure that study site personnel (e.g., investigators, study nurses, clinical study coordinators, clinical research associates, site pharmacists) are well trained in all relevant aspects of clinical trial conduct including: Correct use of the assigned data collection instruments Training in appropriate techniques for interviewing of study subjects/patients [e.g. the use of non-directed questioning, reporting of adverse events as diagnoses (when possible) rather than lists of signs and symptoms, precautions to avoid unblinding]
of a product (i.e., a pill, a solution, etc.) Ambiguous Information (see also MTS:PTC Section 3.4.2): Reported LLT Selected Comment Patient had medical history of AR Ill-defined disorder It is not what medical condition the patient had (aortic regurgitation, arterial restenosis, allergic rhinitis?), so LLT Ill-defined disorder can be selected Conflicting Information (See also MTS:PTC Section 3.4.1): Reported LLT Selected Comment Severe anaemia with a haemoglobin of 19.1 g/dL Haemoglobin abnormal LLT Haemoglobin abnormal covers both of the reported concepts (note: haemoglobin value of 19.2 g/dL is a high result, not a low result as would be expected in severe anaemia Training Appropriate ongoing training is a key part of a good data quality strategy. Training should be to all persons involved in the collection, transcription, categorisation, entry, coding, and review of information. Organisational training practices and procedures should be documented in writing and continually reviewed for updates. Training should be performed by appropriately qualified individuals who are knowledgeable about the organisation’s standardised procedures and focused on compliance. Cross-training of key functions is advisable to ensure a consistent approach and to preserve data quality standards during periods of unexpected personnel changes. that organisations may commonly use unfamiliar or remote study sites for clinical trial conduct, it is also important to ensure that study site personnel (e.g., investigators, study nurses, clinical study coordinators, clinical research associates, site pharmacists) are well trained in all relevant aspects of clinical trial conduct including: Correct use of the assigned data collection instruments Training in appropriate techniques for interviewing of study subjects/patients [e.g. the use of non-directed questioning, reporting of adverse events as diagnoses (when possible) rather than lists of signs and symptoms, precautions to avoid unblinding]