{"content":[{"text":"Medicine is adequately funded to carry out this important mission. Our comments are \n largely focused on the Registration component of clinicaltrials.gov and we have only \n minor comments on the Results Submission section.","bbox":{"left":0.115333,"top":0.088737,"width":0.7369279999999999,"height":0.05612099999999999}},{"text":"Specific Comments:","bbox":{"left":0.115333,"top":0.159495,"width":0.187602,"height":0.020939999999999986}},{"text":"Responsible Party – The NPRM correctly identifies the party responsible for registering \n a clinical trial as either the sponsor or the principal investigator. While in most cases the \n sponsor or the principal investigator is the appropriate party, the NIH may want to \n consider the possibility of a contractor, like a CRO, being designated as the responsible \n party.","bbox":{"left":0.115333,"top":0.194798,"width":0.7590459999999999,"height":0.09157600000000002}},{"text":"Adverse event reporting – ACRO endorses the implementation of a standard vocabulary \n for adverse event reporting and suggest that FDA standards be used with an \n appropriate lag in submission time between FDA reporting and posting in the data bank.","bbox":{"left":0.115333,"top":0.300897,"width":0.763749,"height":0.05612}},{"text":"Clinical trial registration/recruitment information – In general, a full protocol is not \n necessary and a summary protocol may be adequate but the NIH should consider \n adding the “schedule of events” to provide subjects with information on the care that will \n be covered in a given study. Additionally, the inclusion/exclusion criteria must be \n adequate to facilitate, at a minimum, the initial screening and matching of trial \n participants. Here too, standardized terminology should be implemented. The content of \n all updates should be clearly identified. ACRO also recommends that the study be \n identified as being a biosimilar or a bioequivalent trial. If there is a specific biomarker \n that is being sought in the patient population, that should be specified as well. The NIH \n should consider including Phase I protocols, as these would be helpful to participants.","bbox":{"left":0.115333,"top":0.371654,"width":0.761065,"height":0.17993399999999998}},{"text":"Further, there must be standardization of indication names to ensure the usefulness and \n consistency of the data bank. Our members have identified an inconsistency in \n terminology as a major limiting factor for effective patient recruitment. ACRO believes \n the use of SNOMED CT, which has been mapped MeSH, presents the best option to \n ensure uniformity. Other standards that have been mapped to MeSH may be acceptable \n but we believe SNOMED CT provides the most recognizable format and the format that \n will be easiest to integrate into electronic health records, which should be the ultimate \n goal for the data bank. Alternatively, ICD-10 could be considered. More important than \n the specific standard chosen is the ability for that standard to be mapped to EHRs.","bbox":{"left":0.115333,"top":0.566073,"width":0.76532,"height":0.16221999999999992}},{"text":"Administrative data – ACRO strongly endorses the proposal to include the complete \n grant or contract number for any clinical trial that is funded, in whole or in part, by a U.S. \n federal government agency.","bbox":{"left":0.115333,"top":0.742929,"width":0.762095,"height":0.05612100000000009}},{"text":"Facility information – ACRO supports inclusion of contact information for a \n knowledgeable person at each clinical trial site to the extent practicable.","bbox":{"left":0.115333,"top":0.813535,"width":0.6419549999999999,"height":0.03854599999999997}},{"text":"Human Subjects Protection Review Board Status – ACRO agrees that inclusion of \n status of Institutional Review Board/Ethics Committee review would be helpful to","bbox":{"left":0.115333,"top":0.866591,"width":0.711683,"height":0.03854500000000005}}],"images_bbox":[],"images_bbox_not_text_overlap":[]}