Effective Research Data Management (RDM) is a key component of research integrity and reproducible research, and its importance is increasingly emphasised by funding bodies, governments, and research institutions around the world. However, many researchers are unfamiliar with RDM best practices, and research support staff are faced with the difficult task of delivering support to researchers across different disciplines and career stages. What strategies can institutions use to solve these problems?

Engaging Researchers with Data Management is an invaluable collection of 24 case studies, drawn from institutions across the globe, that demonstrate clearly and practically how to engage the research community with RDM. These case studies together illustrate the variety of innovative strategies research institutions have developed to engage with their researchers about managing research data. Each study is presented concisely and clearly, highlighting the essential ingredients that led to its success and challenges encountered along the way. By interviewing key staff about their experiences and the organisational context, the authors of this book have created an essential resource for organisations looking to increase engagement with their research communities.

This handbook is a collaboration by research institutions, for research institutions. It aims not only to inspire and engage, but also to help drive cultural change towards better data management. It has been written for anyone interested in RDM, or simply, good research practice.

Objectives The overall purposes of this first US national pilot study were to (1) test the feasibility of online administration of the Bioethical Issues in Biostatistical Consulting (BIBC) Questionnaire to a random sample of American Statistical Association (ASA) members; (2) determine the prevalence and relative severity of a broad array of bioethical violations requests that are presented to biostatisticians by investigators seeking biostatistical consultations; and (3) establish the sample size needed for a full-size phase II study. Design A descriptive survey as approved and endorsed by the ASA. Participants Administered to a randomly drawn sample of 112 professional biostatisticians who were ASA members. Primary and secondary outcome measures The 18 bioethical violations were first ranked by perceived severity scores, then categorised into three perceived severity subcategories in order to identify seven ‘top tier concern violations’ and seven ‘second tier concern violations’. Results Methodologically, this phase I pilot study demonstrated that the BIBC Questionnaire, as administered online to a random sample of ASA members, served to identify bioethical violations that occurred during biostatistical consultations, and provided data needed to establish the sample size needed for a full-scale phase II study. The No. 1 top tier concern was ‘remove or alter some data records in order to better support the research hypothesis’. The No. 2 top tier concern was ‘interpret the statistical findings based on expectation, not based on actual results’. In total, 14 of the 18 BIBC Questionnaire items, as judged by a combination of ‘severity of violation’ and ‘frequency of occurrence over past 5 years’, were rated by biostatisticians as ‘top tier’ or ‘second tier’ bioethical concerns. Conclusion This pilot study gives clear evidence that researchers make requests of their biostatistical consultants that are not only rated as severe violations, but further that these requests occur quite frequently.

(This case study was added to OER Commons as one of a batch of over 700. It has relevant information which may include medical imagery, lab results, and history where relevant. A link to the final diagnosis can be found at the end of the case study for review. The first paragraph of the case study -- typically, but not always the clinical presentation -- is provided below.)

A 46-year-old woman was admitted to our hospital with chief complaint of numbness of right lower limb lasting 1 year as well as left leg ache lasting 5 months. The symptoms were gradually developing. There was no history of trauma, drug use or any physical exertion. Neurological examination confirmed sense of pain and temperature subsided in left upper limb, left side of body and right lower limb. Radiating pain happened at the left lap and rear waist, and the tendon reflex weakened slightly at left upper limb and right lower limb. A spinal MRI revealed a heterogeneous intensity enhancing 3.0×1.0×1.0cm mass involving T5 through T7 (Figure 1a, b); it was hypointense on T1 (Figure 1c) and hyperintense on T2-weighted sequences (Figure 1d). Short time inversion recovery (STIR) image showed minimal perilesional edema (Figure 1e). The patient subsequently underwent a near total tumour excision via T5-T7 laminectomy approach. Then she underwent craniospinal irradiation and temozolomide chemotherapy. Postoperative follow-up was uneventful with good control in 12 months.

(This case study was added to OER Commons as one of a batch of over 700. It has relevant information which may include medical imagery, lab results, and history where relevant. A link to the final diagnosis can be found at the end of the case study for review. The first paragraph of the case study -- typically, but not always the clinical presentation -- is provided below.)

A 55-year-old male presented to our institution in October, 2016 with a 4-week history of intermittent slight fever and 3-week headache, accompanied by dizziness as well as fatigue, nausea, tinnitus, vision rotation, standing instability and blurred vision. Physical examination revealed no focal neurological deficit. MRI showed a flaky and nodular lesion involving the right cerebellar hemisphere and cerebellar vermis. The lesion was isointense on T2 weighted images, high signal intensity on T1 weighted images with nodular gadolinium enhancement (Figures 1a, 1b). Laboratory investigations revealed a white-cell count of 9780 per mm3 (reference range, 3500 to 9500), and an absolute eosinophil count of 1660 per mm3 (reference range, 20 to 500). A biopsy of the lesion was performed. .