Open the auxiliary access

Firefly Open Source Community

   Login   |   Register   |
New_Topic
Firefly Open Source Community › Embedded Board › ITX-3588J› CCDM通過考試，CCDM软件版
New Topic
Print Previous Topic Next Topic

[Hardware] CCDM通過考試，CCDM软件版

davidha918

136

Credits

0

Prestige

0

Contribution

registered members

Rank: 2

Credits
136

【Hardware】 CCDM通過考試，CCDM软件版

Posted at yesterday 17:53      View：4 | Replies：0        Print      Only Author   [Copy Link] 1#
如果你的預算是有限的，但需要完整的價值包，不如嘗試一下我們Fast2test SCDM的CCDM考試培訓資料。我們Fast2test可以為你的IT認證保駕護航，是目前網路上最受歡迎的最可行的培訓資料網站，CCDM考試是你職業生涯中的一個里程碑，在這種競爭激烈的世界裏，它比以往任何時候都顯得比較重要，我們保證讓你一次輕鬆的通過考試，也讓你以後的工作及日常工作變得有滋有味。還可以幫你挖掘到許多新的途徑和機會。這實在對著起這個價錢，它所創造的價值遠遠大於這個金錢。
Fast2test的CCDM考古題有两种版本，即PDF版和软件版。這樣可以給你最大的方便。PDF版方便你的使用，你可以下載並且將CCDM考古題列印出來以供隨時學習。軟體版類比了真實的考試，可以讓你切身感受到SCDM考試的氣氛。这样在考试时你就可以轻松自如地应对了。
選擇CCDM通過考試 - 不用再擔心Certified Clinical Data Manager考試選擇最適合的SCDM CCDM題庫學習資料，并來獲得認證，它能加速您在信息技術行業里快速成長，也是加薪升遷的成功選擇。在取得您第一個CCDM認證后，您還可以參加其它的IT認證考試，Fast2test的考古題能幫助獲得更多的成功。我們擁有超多十年的IT認證經驗，在我們的支援下，您可以順利的SCDM CCDM考試。我們還承諾，對于使用我們CCDM考古題失敗的考生，將提供100%無條件退款。
SCDM CCDM 考試大綱：
主題簡介
主題 1
  • Coordination and Project Management Tasks: This domain evaluates the skills of a Clinical Systems Analyst in coordinating data management workload, vendor selection, scheduling, cross-team communication, project timeline management, risk handling, metric tracking, and preparing for audits.
主題 2
  • Data Processing Tasks: This section measures skills of Clinical Systems Analysts and focuses on handling, transforming, integrating, reconciling, coding, querying, updating, and archiving study data while maintaining quality, consistency, and proper privileges over the data lifecycle.
主題 3
  • Design Tasks: This section of the CCDM exam measures skills of Data Managers and covers how to design and document data collection instruments, develop workflows and data flows, specify data elements, CRF forms, edit checks, reports, database structure, and define standards and procedures for traceability and auditability.
主題 4
  • Review Tasks: This section measures the skills of Data Managers and involves reviewing protocols, CRFs, data tables, listings, figures, and clinical study reports (CSRs) for consistency, accuracy, and alignment with data handling definitions and regulatory requirements.
主題 5
  • Testing Tasks: This section measures the skills of Data Managers and involves creating test plans, generating test data, executing validation and user acceptance testing, and documenting results to ensure systems and processes perform reliably and according to specifications.

最新的 Clinical Data Management CCDM 免費考試真題 (Q51-Q56):問題 #51
Which Clinical Study Report section would be most useful for a Data Manager to review?
  • A. Description of how data were processed
  • B. Rationale for the study design
  • C. Clinical narratives of adverse events
  • D. Description of statistical analysis methods
答案：A
解題說明：
The section of the Clinical Study Report (CSR) most useful for a Data Manager is the description of how data were processed.
According to the GCDMP (Chapter: Data Quality Assurance and Control), this section details the data handling methodology - including data cleaning, coding, transformation, and derivation procedures - all of which are core responsibilities of data management. Reviewing this section ensures that the data processing methods documented in the CSR align with the Data Management Plan (DMP), Data Validation Plan (DVP), and database specifications.
The statistical methods section (option A) is primarily for biostatistics, and the rationale for study design (option B) pertains to clinical and regulatory affairs. Clinical narratives (option D) are used by medical reviewers, not data managers.
By reviewing how data were processed, the Data Manager verifies that the study data lifecycle-from collection to analysis-was conducted in compliance with regulatory and GCDMP standards.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Quality Assurance and Control, Section 6.3 - Documentation of Data Processing in Clinical Study Reports ICH E3 - Structure and Content of Clinical Study Reports, Section 11.3 - Data Handling and Processing FDA Guidance for Industry: Clinical Study Reports and Data Submission - Data Traceability and Handling Documentation

問題 #52
In development of CRF Completion Guidelines (CCGs), which is a minimum requirement?
  • A. CCGs must be signed before database closure to include all possible protocol changes affecting CRF completion
  • B. CCGs are designed from the perspective of the Study Biostatistician to ensure that the data collected can be analyzed
  • C. CCGs are developed with representatives of Data Management, Biostatistics, and Marketing departments
  • D. CCGs must include a version control on the updated document
答案：D
解題說明：
Case Report Form Completion Guidelines (CCGs) are essential study documents that instruct site staff on how to complete each field of the CRF correctly. A minimum requirement for CCGs, according to Good Clinical Data Management Practices (GCDMP, Chapter: CRF Design and Data Collection), is that they must include version control.
Option A describes an important design consideration but not a minimum compliance requirement. Option B is inaccurate, as CCGs must be approved and implemented before data collection begins, not after. Option D includes an irrelevant stakeholder (Marketing).
Therefore, option C-"CCGs must include a version control on the updated document"-is correct and compliant with CCDM and GCP standards.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: CRF Design and Data Collection, Section 4.3 - Development and Maintenance of CRF Completion Guidelines ICH E6(R2) GCP, Section 8.2.1 - Essential Documents and Version Control Requirements

問題 #53
Which is the best reason why front-end checks are usually kept minimal, when compared to back-end checks, in a paper-based clinical study?
  • A. Data entry staff should be able to enter a value into the database just as it appears in the paper CRF
  • B. There are approvals required to raise a Data Clarification Form which could take time
  • C. There is no need to alert the site personnel immediately about a data issue, as the study has happened already
  • D. Data review can be performed at a later time due to the paper-based studies being smaller in size
答案：A
解題說明：
In paper-based clinical studies, front-end data checks (those performed during data entry) are intentionally kept minimal to ensure that data are entered exactly as recorded on the paper CRF. This principle ensures data integrity by maintaining fidelity between source and electronic records before any cleaning or edit validation occurs.
The GCDMP (Chapter: Data Validation and Cleaning) explains that data entry operators should input values as written, even if they appear incorrect or inconsistent, because the purpose of front-end checks is not to interpret but to capture data faithfully. The back-end edit checks-performed later by data managers-are designed to identify inconsistencies, out-of-range values, or logical errors that require clarification through queries.
This approach separates data capture from data cleaning, minimizing bias and preserving original investigator input. Hence, option A accurately states the rationale for keeping front-end checks minimal in paper-based studies.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Data Validation and Cleaning, Section 4.2 - Data Entry, Edit Checks, and Query Process ICH E6(R2) GCP, Section 5.5.3 - Data Handling and System Controls FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.1 - Data Entry and Verification Processes

問題 #54
On a dose escalation study, the Data Manager notices one site has a much higher number of queries than other sites and most are older than 30 days. The Data Safety Monitoring Board will meet in three weeks. What should the Data Manager providing CRO oversight do?
  • A. Ignore it for now and check back next week
  • B. Notify the CRO's Clinical Leader about the concerns
  • C. Consult the CRO's Lead Data Manager and the CRO's Project Leader
  • D. Call the site directly and ask the study coordinator about the concerns
答案：C
解題說明：
The correct action is to consult the CRO's Lead Data Manager and CRO's Project Leader (Option C) to ensure the issue is addressed through the appropriate oversight and escalation process.
According to the GCDMP (Chapter: Project Management and Communication), when a sponsor Data Manager identifies significant data management issues under CRO oversight - such as aging queries or site performance disparities - communication must follow the established governance and escalation pathway defined in the Scope of Work (SOW) and Data Management Plan (DMP).
Directly contacting the site (Option B) bypasses the CRO's chain of command and violates communication protocols. Notifying only the Clinical Leader (Option A) is insufficient, and ignoring the issue (Option D) jeopardizes the Data Safety Monitoring Board (DSMB) review timeline.
Therefore, Option C ensures a documented, collaborative approach to problem resolution within the contractual oversight structure.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Project Management and Communication, Section 7.1 - Oversight of CRO Data Management Activities ICH E6 (R2) GCP, Section 5.2 - Contract Research Organization Responsibilities FDA Guidance for Industry: Oversight of Clinical Investigations - Sponsor and CRO Roles and Communication Pathways

問題 #55
Which data are needed to monitor site variability in eligibility screening?
  • A. Number of sites with high enrollment
  • B. Number of subjects enrolled
  • C. Number of sites with low enrollment
  • D. Number of subjects screened and number of subjects enrolled
答案：D
解題說明：
To monitor site variability in eligibility screening, you must analyze the number of subjects screened versus the number of subjects enrolled at each site. This allows identification of sites that are over- or under-screening relative to their enrollment yield.
The GCDMP (Chapter: Data Quality Assurance and Metrics) emphasizes that screening-to-enrollment ratios are critical indicators of protocol compliance and data quality. Sites with unusually low conversion rates may have unclear understanding of inclusion/exclusion criteria, requiring targeted training or monitoring.
Other options (A, C, D) provide enrollment metrics but do not reveal screening efficiency or variability, which depend on both screening and enrollment data.
Thus, option B correctly identifies the data necessary for monitoring eligibility screening performance across sites.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Data Quality Assurance and Metrics, Section 5.4 - Site Performance Metrics ICH E6(R2) GCP, Section 5.18 - Monitoring and Site Oversight Requirements

問題 #56
......
您可以先在網上下載Fast2test為你免費提供的關於SCDM CCDM認證考試的練習題及答案作為嘗試，之後你會覺得Fast2test給你通過考試提供了一顆定心丸。選擇Fast2test為你提供的針對性培訓，你可以很輕鬆通過SCDM CCDM 認證考試。
CCDM软件版: https://tw.fast2test.com/CCDM-premium-file.html
https://www.prepawaytest.com
Reply

Use props Report

Return to List
High mode
B Color Image Link Quote Code Smilies
You need to log in before you can reply Login | Register

This forum Credits Rules

  •  

Service Hotline : (+86)18688117175
Contact us
E-mail : global@t-firefly.com
Copyright © 2014-2022, FIREFLY TECHNOLOGY CO.,LTD. All Rightts Reserved. 粤ICP备14022046号-2
Quick Reply Back to top Back to list