Detection and evaluation of signals associated with exposure to individual and combination of medications in pregnancy: a signal detection study protocol by Christopher Yau, Catherine Nelson-Piercy, Krishnarajah Nirantharakumar, Anuradhaa Subramanian, Peter Brocklehurst, Sinead Brophy, Maria Loane, Helen Dolk, Muhammad Usman, Jingya Wang, Colin McCowan, Holly Hope, Jonathan Kennedy, Siang Ing Lee, Amaya Azcoaga-Lorenzo, Gillian Santorelli, Mairead Black, Christine Damase-Michel, Ngawai Moss, Katherine Phillips, Kelly-Ann Eastwood, Kathryn Mary Abel, Lisa Kent, Adeniyi Fagbamigbe, Dermot OReilly, Steven Wambua, Megha Singh, Mohamed Mhereeg, Neil Cockburn, Sudasing Pathirannehelage Buddhika Hemali Sudasinghe

“…Through group discussion, the expert team will reach consensus on each of the medication exposure–outcome signal, thereby excluding spurious signals, leaving signals suggestive of causal associations for further evaluation.Ethics and dissemination Ethical approval has been obtained from the Independent Scientific Advisory Committee, SAIL Information Governance Review Panel, University of St. Andrews Teaching and Research Ethics Committee and Office for Research Ethics Committees Northern Ireland (ORECNI) for access and use of CPRD, SAIL, SMR and NIMATS data, respectively.…”
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