Diary cards

Electronic Diary Cards are portable, hand-held systems designed to be programmed according to specific protocol requirements and are used by patients to record directly information on their condition and medication consumption during a particular study. They should be specified and designed so that they are highly prescriptive since they are used in a relatively uncontrolled environment (e.g., subject s home). Specific considerations for the validation of electronic diary cards are ... 

All research personnel must search for clues about safety events from many sources, such as information in clinical records at the study sites information in data collection forms (e.g. CRFs, diary cards, quality-of-life forms, psychiatric rating scales, etc.), occurrence of missed and/or unscheduled visits, dropouts and withdrawals use of any concomitant medications/devices and abnormal laboratory data. AEs may also occur simply as a result of study procedures and study participation. Information about definitions of AEs and requirements for reporting AEs must be clearly stated in the protocol and explained to the site staff, who must also be educated in the correct procedure and immediate requirement for reporting any AE suspected to be serious or unexpected as per the regulatory definitions. 

Verify accuracy and completeness of recorded data in CRFs, including diary cards, quality of life forms, registration forms, consent forms, etc., by comparing with the original source documents (clinic or hospital records). Where discrepancies are found, arrangements must be made for corrections and resolution. Resolve any outstanding... 

Visit dates. All visit dates should be recorded in the medical file. Interim visit dates recorded in the medical file, but not in the CRF, should be noted by the monitor in case they signify occurrence of AEs or protocol violations. The final visit date should be so indicated, for example study finished or withdrew from study AEs. All AEs noted in the medical file during the time period specified by the protocol must be recorded in the CRF. The monitor must also carefully check other documents (e.g. diary cards, quality of life forms) for sources of information about AEs. Occurrence of out-of-range laboratory values, which are considered to be clinically significant by the investigator, must be reported and assessed as AEs... 

Compliance with medication/device use (by the study subject) should be assessed in all studies. If supplies are dispensed to subjects for selfadministration, methods to assure compliance (e.g. diary cards, instructions on labeling, supervised administration) and methods to check compliance (e.g. tablet counts, plasma/urine assays, diary card review) must be in place. At each study visit, the study subjects should be asked to... 

Fig. 1. Diary Card intoxication scores. BL, baseline. DB, double-blind. Patients self-titrated active medication (THCCBD) or placebo against symptom relief or intolerable unwanted effects. Doses reached a plateau after 4 weeks. Open patients from both arms re-titrated onto active medication. (Reproduced with kind permission from Arnold Publishers)...

Several authors (Rasmussen et al, 2001 Knudsen et al, 2002 Voelzke et al, 2003) stated that food questionnaires are refiable instruments to assess a population s iodine intake. However, there are indications that self-estimations concerning iodine intake recorded on a diary card are unreliable when compared with iodine intakes obtained by direct analysis of real diets (Lightowler and Davis, 2002). 

Any document used to collect research data on clinical study subjects may be genetically classed as a data collection form. These completed forms provide evidence of the research conducted. The most common type of data collection form is the CRF. Other types of data collection forms include diary cards, dispensing records, quality of life forms, etc. The CRF must allow for proper analysis of the data and proper reporting of the data in the final clinical study report and it must reflect the protocol exactly no more and no less data must be collected. Thus, a CRF must be created for each clinical study and must be prepared in parallel with the protocol. CRFs are usually also prepared by spon-sors/CROs in pharmaceutical industry research because of the demanding requirements for their design and contents. 

The GMC secretariat will acknowledge receipt of the statutory declaration, and will subsequently request any additional documents considered necessary to process the case before or after it has been considered by the preliminary screener. Every complaint is scrutinized meticulously, and if it appears that the evidence submitted is insufficient, the GMC s lawyers (solicitors) may be asked to make enquiries to establish additional facts. Cases recently submitted by the industry have nearly all provided sufficient evidence for this stage to be unnecessary. Nevertheless, it may not be possible for a pharmaceutical company to obtain access to patients themselves, e.g. to verify whether the patients had completed diary cards submitted by the doctor concerned, before deciding to refer a matter to the GMC. If the GMC considered such verification necessary, it... 

One cannot expect classification systems for events as complicated, varied, and idiosyncratic as the possible collective of adverse events to be ideal, but some methods can enhance the quality of these data. For certain events, diaries provide a systematic approach to collection. For example, in trials of vaccines, the participant fills out a daily diary card identifying events they experience in the immediate days after immunization from a list of expected adverse events that often occur at such times. 

Live vaccines always trigger concern when given to immunocompromised individuals. Previously the zoster and varicella vaccines have not been recommended in transplant recipients. A study looked at the use of the varicella vaccine in paediatric liver transplant patients. Thirty-six children were vaccinated and followed up with diary cards and phone calls. Importantly, no breakthrough zoster disease was seen. The vaccine was also sufficiently seroprotective, with 97% of study participants maintaining their seroprotective titres at the long-term follow-up (median 4.1years) [78 ]. 

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