電子カルテ(EMR: Electronic Medical Record)のデータを臨床研究に供する試みは，大別して電子カルテの機能（テンプレート等）を拡張して臨床研究にかかわるデータを蓄積する方法(1, 2)と，EDC(Electronic Data Capture)に電子カルテのデータを取り込む方法がある(3, 4)．
Yamamoto K, Yamanaka K, Hatano E, Sumi E, Ishii T, Taura K, et al. An eClinical trial system for cancer that integrates with clinical pathways and electronic medical records. Clinical trials. 2012;9(4):408-17.
Single-Case Design, Analysis, and Quality Assessment for Intervention Research. Lobo et al., J Neurol Phys Ther. 2017 Jul; 41(3): 187–197. doi: 10.1097/NPT.0000000000000187 PMCID: PMC5492992 NIHMSID: NIHMS870756 PMID: 28628553 Single-case (SC) studies have been identified by a variety of names, including “n of 1 studies” and “single-subject” studies. The term “single-case study” is preferred over the previously mentioned terms because previous terms suggest these studies include only one participant. In fact, as will be discussed below, for purposes of replication and improved generalizability, the strongest SC studies commonly include more than one participant. … In SC studies, measurements of outcome (dependent variables) are recorded repeatedly for individual participants across time and varying levels of an intervention (independent variables).
SINGLE CASE DESIGN BRIEFSingle case design (SCD), often referred to as single subject design, is an evaluation method that can be used to rigorously test the success of an intervention or treatment on a particular case (i.e., a person, school, community) and to also provide evidence about the general effectiveness of an intervention using a relatively small sample size. … One of the most notable features of SCD research is that each case serves as its own control, therefore eliminating the need for a control group condition typically required of experimental designs. Specifically, the baseline period serves as the control, which can then be compared to the period after and/or during the intervention phase that follows.
Stephen Morley著 Single Case Methods in Clinical Psychology: A Practical Guide 2017/12/12
David Barlow, Matthew Nock, Michael Hersen 著 Single Case Experimental Designs: Strategies for Studying Behavior Change 2008/2/26