Drug development in general and clinical trials in particular is expensive and time consuming processes. One mandatory procedure in clinical trials are data collection, about 15 years ago almost all data were collected with a paper based approach but with new digitalised technology for data collection the process were about to become more efficient in regard to time, cost and quality of data. However the adoption rate of these systems for data collection were much lower than anticipated and most previous research points toward poorly developed products as the main reason for the adoption failure. Nevertheless, these systems have become more user friendly and efficient and today almost all studies use Electronic Data Capture (EDC) as the primary method for data collection. This project aim to investigate if the reason for the slow diffusion was a result of poorly developed products or if there are external factors such as social or organisational aspects that caused this delay. Semi structured interviews were conducted with 15 informants who works with EDC systems daily and are professionals within this industry. The result indicates that the slow diffusion is partly caused by initially bad systems that in turn might have caused a resistance among the end users and partly caused by slow decision organisations such as multinational pharmaceutical companies. The advice given to the project owner who intends to acquire this market is to focus on electronic Patient Reported Outcome (ePRO), which is a tool used by individual patients for self-reporting of data in clinical trials. ePRO is an extension of the EDC systems and must be user friendly for the patients and easy to connect to other systems. The company should rather focus on small Contract Research Organisation (CRO) as main customers rather than Big Pharma. Big Pharma often conduct multinational studies and decisions regarding the protocol and how data is to be collected are centrally decided. Since the project owner is a newly started, small firm with limited experience of clinical trials my advice would be to target CROs that conduct smaller studies.

Despite the development of injury surveillance systems for use at large multi sportsevents (Junge 2008), their implementation is still methodologically and practicallychallenging. Edouard (2013) and Engebretsen (2013) have pointed out that thecontext of athletics championships feature unique constraints, such as a limiteddata-collection window and large amounts of data to be recorded and rapidlyvalidated. To manage these logistical issues, Electronic Data Capture (EDC) methodshave been proposed (Bjorneboe 2009, Alonso 2012, Edouard 2013). EDC systemshave successfully been used for surveillance during multi-sport events Derman et al(2013) and its potential for surveillance studies during athletics championships istherefore interesting. The focus for surveillance during athletics championships hasthis far been on injury and illness data collected from team medical staff in directassociation to the competitions. But the most common injury and illness problems inathletics are overuse syndromes (Alonso 2009, Edouard 2012, Jacobsson 2013) andknowledge of risk factors associated to these problems is also relevant in associationto championships. A desirable next step to extend the surveillance routines istherefore to include also pre-participation risk factors. For surveillance of overusesyndromes, online systems for athlete self-report of data on pain and othersymptoms have been reported superior to reports from coaches (Shiff 2010). EDCsystems have also been applied for athlete self-report of exposure and injury data inathletics and other individual sports and have been found to be well accepted with agood efficiency (Jacobsson 2013, Clarsen 2013). There are thus reasons forinvestigating EDC system use by both athletes and team medical staff during athleticchampionships.This thesis used a cross-sectional design to collect qualitative data from athletes andteam medical staff using interviews and “think-aloud” usability evaluation methods(Ericsson 1993; Kuusela 2000). It was performed over 3 days during the 2013European Athletics Indoor Championships in Gothenburg, Sweden. Online EDCsystems for collection of data from athletes and team medical staff, respectively,were prepared for the study. The system for use by team medical staff was intendedto collect data on injuries and illnesses sustained during the championship and thesystem for athletes to collect data on risk factors.This study does not provide a solution in how an EDC effort should be implementedduring athletics championships. It does however points towards usability factorsthat needs to be taken into consideration if taking such an approach.