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It specifies clinician and monitor review during screening, eligibility criteria, prohibited and cautionary medications, and the process for private MD notification.","https://schema.org",{"og:url":32,"og:type":74,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":76,"canonical":32},"index,follow",{"doc_id":78,"site_id":7},243293,1789202293,{"code":4,"msg":81,"data":82},"success",[83,88,93,98,103,108,113,118,123],{"id":84,"doc_module":22,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},11,"Presentations",90,"presentations",{"id":89,"doc_module":22,"doc_module_name":25,"category_name":90,"show_sort_weight":91,"slug":92},12,"Resumes",80,"resumes",{"id":94,"doc_module":22,"doc_module_name":25,"category_name":95,"show_sort_weight":96,"slug":97},14,"Invoices",70,"invoices",{"id":99,"doc_module":22,"doc_module_name":25,"category_name":100,"show_sort_weight":101,"slug":102},15,"Posters",60,"posters",{"id":104,"doc_module":22,"doc_module_name":25,"category_name":105,"show_sort_weight":106,"slug":107},16,"Social Media",50,"social-media",{"id":109,"doc_module":22,"doc_module_name":25,"category_name":110,"show_sort_weight":111,"slug":112},17,"Forms",40,"forms",{"id":114,"doc_module":22,"doc_module_name":25,"category_name":115,"show_sort_weight":116,"slug":117},18,"Letters",30,"letters",{"id":119,"doc_module":22,"doc_module_name":25,"category_name":120,"show_sort_weight":121,"slug":122},21,"Paper Templates",5,"papers-templates",{"id":124,"doc_module":22,"doc_module_name":25,"category_name":29,"show_sort_weight":4,"slug":125},158,"general-158",{"code":4,"msg":81,"data":127},{"doc_id":78,"user_id":128,"nickname":42,"user_avatar":129,"doc_module":22,"category_id":124,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":30,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":135,"language":136,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":12,"update_tm":79,"read_time":140},4398048949847,"https://ap-avatar.wpscdn.com/avatar/400002536579ef2da7f?_k=1778318612642679267","ADNI4 Procedures Manual v2.0  \nALZHEIMER’S DISEASE NEUROIMAGING INITIATIVE 4: IN-CLINIC  \nConfidentiality Statement  \nThe information in this document is privileged or confidential and may not be disclosed unless such disclosure is required by applicable laws and regulations. It is the property of ATRI and should not be copied by or distributed to persons not involved in the study. Persons to whom the information is disclosed must be informed that the information is privileged or confidential and may not be further disclosed by them. These restrictions on disclosure will apply equally to all future information supplied to you, which is indicated as privileged or confidential. Any unauthorized review, use, disclosure, copying or distribution is strictly prohibited.  \nCHAPTER 1: PROTOCOL SYNOPSIS ..................................................................................................................................... 4  \n1.1 PROTOCOL SYNOPSIS.................................................................................................................................. 4  \nCHAPTER 2: SITE APPROVAL AND START-UP........................................................................................................................ 5  \n2.2 CONTRACTS................................................................................................................................................ 5  \n2.3 PET SCANNER CERTIFICATION ..................................................................................................................... 5  \n2.4 MRI SCANNER CERTIFICATION..................................................................................................................... 5  \n2.5 PERSONNEL REQUIREMENTS....................................................................................................................... 6  \n2.6 REGULATORY REQUIREMENTS .................................................................................................................... 8  \nCHAPTER 3: CERTIFICATION, TRAINING AND EXPERIENCE ....................................................................................................... 8  \n3.1 ADAS-COG CERTIFICATION .......................................................................................................................... 9  \n3.2 CLINICAL DEMENTIA RATING (CDR) CERTIFICATION...................................................................................... 9  \n3.3 ADNI4-ELECTRONIC DATA CAPTURE (EDC)................................................................................................ 10  \n3.4 ADNI4 – GLOBAL UNIQUE IDENTIFIER (GUID) ............................................................................................. 10  \n3.5 ADNI4 – AMYLOID PET DISCLOSURE .......................................................................................................... 11  \nCHAPTER 4: RECRUITMENT AND RETENTION ...................................................................................................................... 11  \n4.1 OVERALL ADNI4 RECRUITMENT AND RETENTION....................................................................................... 11  \n4.2 ATRI RECRUITMENT AND RETENTION SUPPORT ......................................................................................... 13  \n4.2.1 ATRI R&R MATERIALS ............................................................................................................................ 13  \n4.3 ADDITIONAL RECRUITMENT SUPPORT....................................................................................................... 14  \n4.4 ALANIZ MARKETING ................................................................................................................................. 14  \n4.5 REFERRALS FROM EBISU – ADNI INVESTIGATOR PORTAL............................................................................ 14  \nCHAPTER 5: GENERAL INFORMATION .......................................","cbCaivbcvQVzPQx0","https://ap.wps.com/l/cbCaivbcvQVzPQx0","pdf",2713433,92,"English","# CHAPTER 1: PROTOCOL SYNOPSIS\n## 1.1 PROTOCOL SYNOPSIS\n# CHAPTER 2: SITE APPROVAL AND START-UP\n## 2.2 CONTRACTS\n## 2.3 PET SCANNER CERTIFICATION\n## 2.4 MRI SCANNER CERTIFICATION\n## 2.5 PERSONNEL REQUIREMENTS\n## 2.6 REGULATORY REQUIREMENTS\n# CHAPTER 3: CERTIFICATION, TRAINING AND EXPERIENCE\n## 3.1 ADAS-COG CERTIFICATION\n## 3.2 CLINICAL DEMENTIA RATING (CDR) CERTIFICATION\n## 3.3 ADNI4-ELECTRONIC DATA CAPTURE (EDC)\n## 3.4 ADNI4 – GLOBAL UNIQUE IDENTIFIER (GUID)\n## 3.5 ADNI4 – AMYLOID PET DISCLOSURE\n# CHAPTER 4: RECRUITMENT AND RETENTION\n## 4.1 OVERALL ADNI4 RECRUITMENT AND RETENTION\n## 4.2 ATRI RECRUITMENT AND RETENTION SUPPORT\n## 4.2.1 ATRI R&R MATERIALS\n## 4.3 ADDITIONAL RECRUITMENT SUPPORT\n## 4.4 ALANIZ MARKETING\n## 4.5 REFERRALS FROM EBISU – ADNI INVESTIGATOR PORTAL\n# CHAPTER 5: GENERAL INFORMATION\n## 5.1 STUDY SUPPLIES\n## 5.1.1 ATRI PROVIDED SUPPLIES\n## 5.1.2 LABORATORY SUPPLIES PROVIDED BY URMC\n## 5.1.3 OVERVIEW OF SYSTEMS\n# CHAPTER 6: NEW ENROLLEES–SCREENING PROCEDURES\n## 6.1 SCREENING OVERVIEW\n## 6.2 DATA FLOW\n## 6.3 CLINICIAN AND MONITOR REVIEW DURING SCREENING\n## 6.4 ELIGIBILITY CRITERIA\n## 6.5 PROHIBITED AND CAUTIONARY MEDICATIONS\n## 6.6 PRIVATE MD NOTIFICATION\n# CHAPTER 7: NEW ENROLLEES– BASELINE\n## 7.1 BASELINE OVERVIEW","[{\"question\":\"What confidentiality restrictions apply in the ADNI4 procedures manual?\",\"answer\":\"The document states that information is privileged or confidential and may not be disclosed unless required by applicable laws and regulations. Unauthorized review, use, disclosure, copying, or distribution is strictly prohibited, and future supplied information is covered by the same restrictions.\"},{\"question\":\"What certification and training topics are covered for study personnel?\",\"answer\":\"The manual includes ADAS-COG certification and Clinical Dementia Rating (CDR) certification. It also covers ADNI4 electronic data capture (EDC), global unique identifier (GUID), and amyloid PET disclosure requirements.\"},{\"question\":\"How does the manual guide new enrollee screening procedures?\",\"answer\":\"It provides a screening overview and details data flow. It specifies clinician and monitor review during screening, eligibility criteria, prohibited and cautionary medications, and the process for private MD notification.\"}]","ADNI4 Procedures Manual - v2.0 | PDF",32]