[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-170969-105":53,"doc-detail-170969-en":127},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":120,"head_meta":122,"extra_data":124,"updated_unix":126},105,"en","dcp-baseline-and-adverse-event-reporting-guidelines","DCP Baseline and Adverse Event Reporting Guidelines","","Guidelines define how to document adverse events that occur after baseline assessment in DCP clinical trials. They distinguish baseline signs, symptoms, abnormal laboratory values, and diagnoses from AEs based on worsening severity, increased frequency, grade changes, persistence, resolution, and recurrence. The document explains when abnormal labs of clinical significance must be reported, how to handle unknown significance via retesting, and how to record onset dates and grading using the CTCAE version specified in the protocol. It also clarifies reporting responsibilities within AE CRFs and references applicable safety reporting regulations.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":41,"@type":70,"position":76},"https://docshare.wps.com/template/letters/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/dcp-baseline-and-adverse-event-reporting-guidelines/170969/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/dcp-baseline-and-adverse-event-reporting-guidelines/170969.png","ImageObject",442,249,{"name":88,"@type":89},"Caleb Sterling","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-20","2026-09-01",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",7,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"How should signs or symptoms present at baseline be recorded?","Question",{"text":109,"@type":110},"Report a baseline sign or symptom as such on the appropriate CRF, not as an AE. Report it as an AE only if severity worsens or frequency increases after baseline.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"When do abnormal laboratory values after baseline need to be reported as AEs?",{"text":114,"@type":110},"Report abnormal laboratory values as AEs only when they are judged clinically significant by the physician. Values judged not clinically significant should not be reported, and unknown significance requires further follow-up or retesting.",{"name":116,"@type":107,"acceptedAnswer":117},"How are onset dates handled for AEs due to worsening or recurrence?",{"text":118,"@type":110},"For baseline items that worsen, use the date when the increase in severity or frequency was first observed as the onset date. If they resolve and then recur, record the recurrence date as the onset date of the new AE.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},170969,1788278351,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":40,"category_name":41,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":47,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":126,"read_time":73},962084925290,"https://ap-avatar.wpscdn.com/davatar_085a072bc5b1113ac321206ff7593b45","DCP Baseline and Adverse Event Reporting Guidelines\nPurpose\nTo clarify the definition and documentation of adverse events occurring after baseline assessment for clinical trials conducted by DCP.\nDefinitions\nBackground\nICH E6(R2)3 is the definitive resource for Good Clinical Practice (GCP). A companion publication, GCP: A Question and Answer Reference Guide4, provides the following guidance regarding the reporting of baseline signs and symptoms:\n“…protocols may also require the structured collection of signs and symptoms…to establish a baseline against which post-treatment AEs can be compared.”\nDCP has adopted this interpretation in its studies to ensure that AEs are appropriately reported and evaluated for attribution. Thus, the DCP protocol template (section on Reportable AEs) states that all AEs that occur “after the informed consent is signed and baseline assessments are completed (including run-in) must be recorded on the AE CRF (paper and/or electronic) whether or not related to study agent.”\nThe following provides instructions for reporting signs, symptoms, and diagnoses/diseases documented at and after informed consent and baseline assessment(s).\nGeneral Approach to Reporting Baseline Assessments vs. AEs\nA sign or symptom present at the baseline assessment(s) should be reported as such on the appropriate CRF, and not as an AE.\nAn abnormal laboratory value documented as part of the baseline assessment(s) should not be reported as an AE, regardless of clinical significance.\nA sign or symptom documented at baseline should be reported as an AE only if the severity worsens or the frequency increases after the baseline assessment.\nA diagnosis or disease documented at baseline should be reported as medical history on the appropriate CRF.\nA pre-existing diagnosis or disease is reported as an AE only if the grade worsens after the baseline medical history.\nThe version of CTCAE identified in the protocol for grading the severity of AEs should be used to grade baseline signs, symptoms, abnormal laboratory values, diseases, or diagnoses.\nReporting Abnormal Laboratory Values After the Baseline Assessment\nAfter the baseline assessment, all abnormal laboratory values determined to be of clinical significance based on the physician’s assessment are to be reported as AEs on the appropriate CRF.\nThose abnormal laboratory values determined to be of no clinical significance or of unknown clinical significance (per the physician’s assessment) should not be reported as AEs.\nAny laboratory value of unknown clinical significance should continue to be investigated/followed-up further for a final determination, if possible.\nIf the clinical significance is unknown and a retest (i.e., an immediate repeat of the laboratory test) is done to confirm the laboratory value, then both results should be entered into the database of record (one for the first test and one for the retest).\nIf the retest confirms the first laboratory value and the investigator deems it as clinically significant, both results should be marked as clinically significant, and the start date for the AE should be the date the first test was done.\nIf the retest does not confirm the laboratory value and the investigator deems the result as not clinically significant, there is no AE to report.\nReporting Other Signs After the Baseline Assessment\nPersistent Unchanged Baseline Signs or Symptoms\nA baseline sign or symptom that persists unchanged throughout the study is not reported as an AE.\nBaseline Signs or Symptoms that Increase in Severity or Frequency\nIf a baseline sign or symptom increases in severity or frequency during the study, it should be reported as an AE.\nThe date on which the increase in severity or frequency was observed is reported as the onset date. For example, if a baseline sign or symptom is noted as grade 1 and is later reported as grade 3 during the study, it should be reported as a grade 3 AE with the onset date the date on which the increase in severity was obser","cbCaieov80Y004JW","https://ap.wps.com/l/cbCaieov80Y004JW","docx",36668,"English","# Purpose\n# Definitions\n## General Approach to Reporting Baseline Assessments vs. AEs\n## Reporting Abnormal Laboratory Values After the Baseline Assessment\n## Reporting Other Signs After the Baseline Assessment\n## Reporting New Diagnoses or Revisions to Medical History After the Baseline Assessment\n# Questions\n# References","[{\"question\":\"How should signs or symptoms present at baseline be recorded?\",\"answer\":\"Report a baseline sign or symptom as such on the appropriate CRF, not as an AE. Report it as an AE only if severity worsens or frequency increases after baseline.\"},{\"question\":\"When do abnormal laboratory values after baseline need to be reported as AEs?\",\"answer\":\"Report abnormal laboratory values as AEs only when they are judged clinically significant by the physician. Values judged not clinically significant should not be reported, and unknown significance requires further follow-up or retesting.\"},{\"question\":\"How are onset dates handled for AEs due to worsening or recurrence?\",\"answer\":\"For baseline items that worsen, use the date when the increase in severity or frequency was first observed as the onset date. If they resolve and then recur, record the recurrence date as the onset date of the new AE.\"}]","DCP Baseline and Adverse Event Reporting Guidelines | DOCX"]