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It details protocol organization, including contact information, ADCS coordinating center roles, and clinical monitoring responsibilities. The manual covers start-up and general information such as personnel requirements, site approval, MRI and PET certification, sample visit scheduling, data management, recruitment and retention, and study close-out. 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It also provides a protocol overview with protocol summary and the schedule of assessments.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"What start-up tasks must be completed before enrollment begins?",{"text":117,"@type":113},"The manual specifies personnel requirements, site approval to begin enrollment, MRI and PET certification, and preparation of study supplies. It also covers sample visit scheduling and general guidelines.",{"name":119,"@type":110,"acceptedAnswer":120},"How are new enrollees screened and followed up?",{"text":121,"@type":113},"Screening procedures include participant identifiers, data flow, rules for screen failures and rescreens, inclusion and exclusion criteria, and screening assessments such as blood draws. Baseline and follow-up procedures define baseline, month 3, month 6, annual in-clinic visits, and interim telephone checks.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},639750,1792705079,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":14,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":129,"read_time":144,"preview_page_count":4},2336478945519,"https://ap-avatar.wpscdn.com/davatar_085a072bc5b1113ac321206ff7593b45","~~ A~~D NI 2  \nDefining Alzheimer's Disease  \nPROCEDURES MANUAL  \nTable of Contents  \nCONTACT INFORMATION  \nProtocol Staff........................................................................................................................................................... 1  \nADCS Coordinating Center ................................................................................................................................ 2  \nADCS Clinical Monitors........................................................................................................................................ 3  \nPROTOCOL OVERVIEW  \nProtocol Summary ................................................................................................................................................ 4  \nSchedule of Assessments ................................................................................................................................... 6  \nSTART-UP AND GENERAL INFORMATION  \nPersonnel Requirements .................................................................................................................................... 9  \nSite Approval to Begin Enrollment.................................................................................................................. 11  \nMRI Certification .................................................................................................................................................... 12  \nPET Certification .................................................................................................................................................... 12  \nStudy Supplies........................................................................................................................................................ 13  \nADNI2 Sample Visit Schedule & General Guidelines for Scheduling Participant Visits ................ 14  \nData Management ................................................................................................................................................ 15  \nClinical Monitoring ............................................................................................................................................... 18  \nStudy Close-Out..................................................................................................................................................... 19  \nUse of Multiple Locations at a Single Center............................................................................................... 20  \nRecruitment and Retention ............................................................................................................................... 20  \nNEW ENROLLEES: SCREENING PROCEDURES  \nSummary .................................................................................................................................................................. 22  \nParticipant Identifiers........................................................................................................................................... 22  \nData Flow ................................................................................................................................................................. 25  \nScreen Failures and Rescreens.......................................................................................................................... 26  \nInclusion Criteria: NEW Participants-CN, EMCI, LMCI, AD ..................................................................... 27  \nExclusion Criteria: NEW Participants-CN, EMCI, LMCI, AD .................................................................... 30  \nExcluded Medications.......................................................................................................................................... 32  \nPermitted Medications ..............................................................................................................","cbCaipnJu0pzL2E5","https://ap.wps.com/l/cbCaipnJu0pzL2E5","pdf",3497144,176,"English","# Table of Contents\n## CONTACT INFORMATION\n## Protocol Staff\n## ADCS Coordinating Center\n## ADCS Clinical Monitors\n## PROTOCOL OVERVIEW\n## Protocol Summary\n## Schedule of Assessments\n## START-UP AND GENERAL INFORMATION\n## Personnel Requirements\n## Site Approval to Begin Enrollment\n## MRI Certification\n## PET Certification\n## Study Supplies\n## Data Management\n## Clinical Monitoring\n## Study Close-Out\n## Recruitment and Retention\n## NEW ENROLLEES: SCREENING PROCEDURES\n## Summary\n## Participant Identifiers\n## Data Flow\n## Screen Failures and Rescreens\n## Inclusion Criteria: NEW Participants\n## Exclusion Criteria: NEW Participants\n## Excluded Medications\n## Permitted Medications\n## Screening Assessments\n## NEW ENROLLEES: BASELINE AND FOLLOW-UP PROCEDURES\n## Baseline Visit\n## Month 3 Visit\n## Month 6 Visit\n## Annual In-Clinic Visit\n## 6 Month Interim Telephone Check\n## FOLLOW-UP PARTICIPANTS: CN, LMCI, EMCI, VISIT PROCEDURES\n## Initial ADNI2 Visit and Follow-Up Visits\n## Telephone Visit Option","[{\"question\":\"What sections does the manual include for protocol organization?\",\"answer\":\"It includes contact information, protocol staff roles, ADCS coordinating center responsibilities, and ADCS clinical monitors. It also provides a protocol overview with protocol summary and the schedule of assessments.\"},{\"question\":\"What start-up tasks must be completed before enrollment begins?\",\"answer\":\"The manual specifies personnel requirements, site approval to begin enrollment, MRI and PET certification, and preparation of study supplies. It also covers sample visit scheduling and general guidelines.\"},{\"question\":\"How are new enrollees screened and followed up?\",\"answer\":\"Screening procedures include participant identifiers, data flow, rules for screen failures and rescreens, inclusion and exclusion criteria, and screening assessments such as blood draws. Baseline and follow-up procedures define baseline, month 3, month 6, annual in-clinic visits, and interim telephone checks.\"}]","ADNI2 Procedures Manual - DEFINING Alzheimer's Disease - Table of Contents - Protocol Overview | PDF",444]