What are the competencies required for CDMcertification?

What are the competencies required for CDM certification?

Competency domains have been divided to reflect how they are mapped within the three sections of the exam.

Competencies
Overall - Intro to CDM
001. Understands the drug development or clinical trial process and those roles, tasks and activities for which Clinical Data Managers assume responsibility.
002. Understands regulatory guidelines (e.g. GCP, 21 CFR 11) and company's interpretation of guidelines.
Protocol Review
003. Understands the protocol content.
004. Understands and interprets primary and secondary hypotheses.
005. Identifies critical data elements used for analysis and reporting.
006. Is able to suggest changes that will ensure good study design.
007. Assures consistency internal to the protocol and the goals of the study/program.
008. Identifies gaps in protocol detail that are necessary for successful CRF design, database design, data cleaning and evaluation of study results and safety data reporting.
009. Challenges unnecessary data collection and contribution to study objectives.
010. Documents the process, procedures and standards for protocol review.
011. Develops checklist(s) and provides training on protocol review.
Data Management Plans
025. Understands the key elements of a data management plan.
026. Defines elements required in a data management plan.
027. Builds new plans based on templates and plans from similar protocol types.
028. Gathers input from specialists in various areas to build the details of the data management plan.
029. Defines the flow of CRFs and DCFs (DM Process).
030. Outlines all other data flow including external data sources.
031. Identifies problem areas for a study - works through defining resolutions, checks, etc.
032. Defines new data management requirements for new, complex projects based on protocol and disease under study.
033. Relates disease area under study to data management requirements to outline all areas of data management plan.
034. Defines all in-process data quality control steps and procedures and metrics.
035. Documents the process, SOPs and standards for creating, approving, and maintaining Data Management Plans.
Communication of Data Trends
092. Uses established guidelines to identify and communicate trends in data.
093. Reviews data for safety or efficacy at aggregate and site levels and identifies clear trends.
094. Generates standard reports (including graphical presentations) of trends in patient data.
095. Develops reports and tools for identifying signals that will identify fraud, misunderstandings, or misconduct.
096. Utilizes simple reporting tools to assess outlier values and summarize results.
097. Develops ad hoc reports for clinical team as required.
098. Documents and maintains process, SOPs and standards for identifying signals and trends in data.
Processing Local Lab Data (CRF Collection)
148. Understands the fundamentals of management of local laboratory data including the specification and checking of normal ranges and units and QC of ranges and units against listings from the patient database.
149. Develops data base specifications, collecting, processing and reporting for lab data.
150. Generates standard reports of missing local laboratory data from the patient database.
151. Defines the types of edit checks that are run against the data.
152. Runs edit checks against the data.
153. Runs standard laboratory data review software on local lab patient data in the patient database.
154. Exhibits expertise in the area of laboratory data and its potential problems.
Processing (loading/merging) Central Lab Data or Other Electronic Data
155. Understands the fundamentals of management of central laboratory data and other types of electronic data.
156. Understands the structure and use of a control or metafile.
157. Utilizes metafiles or control files, vendor data files and loading software to load electronic data routinely.
158. Develops and maintains process, SOPs and standards for processing and maintaining electronic data and associated control files or normal range files.
159. Defines required file format specifications for electronic files and instruct the labs or vendors in the content.
160. Communicates with vendors to define schedule and process for transfers of data.
161. Defines novel strategy for management of Central Laboratories or suppliers of electronic data.
162. Builds preprocessing code for vendor files.
163. Define quality acceptance criteria for electronic data as well as procedures for handling exceptions or violations to standard.
Maintenance of Lab Normal Range Info.
164. Understands different types of lab tests and units appropriate to those tests.
165. Understands when normal ranges should be updated.
166. Performs lab unit conversions.
167. Defines and assures quality conversions for units.
168. Determines when new ranges should be entered into a database.
169. Determines alternatives to lab normal ranges; e.g. use of textbook ranges.
170. Defines and applies laboratory data normalization techniques, as appropriate.
Application of Randomization Schemes (Breaking the Blind)
173. Understands issues related to access to unblinded data.
174. Understands what randomization schemes are and their importance.
176. Understands when randomization codes get applied.
177. Understands how they may be applied to the database (i.e. Batch loaded, entered manually).
Database Lock Procedures
179. Ensures that all steps preparatory to locking are accomplished, e.g.: patients are received, unverified records resolved, all edit checks are resolved, all lab data loaded, all data clarification queries have been returned from sites, all coding comp.
180. Understands the steps in locking databases.
181. Understands the concept of "frozen" data.
182. Removes all unauthorized access and informs users.
183. Documents the locking procedure followed and any deviations from it.
184. Develops and maintains process and SOPs standards relevant to database locking and unlocking.
185. Establishes and coordinates the timely completion of the database lock procedures.
186. Understands and follows the process if the database needs to be unlocked.
CRO-Sponsor Partnership
227. Communicates on daily issues and questions.
228. Understands roles/responsibilities between CRO and sponsor.
229. Defines roles, responsibilities and rules of engagement appropriate to the business context.
231. Reviews CRO data management plan. Alternatively, develop the CRO data management plan.
232. Requests, reviews and comments on regular status reports from the CRO contacts. Alternatively, creates, and explains the study status to the sponsor.
233. Provides oversight and QC of CRO activities. Alternatively, coordinates the CRO activities with those of the sponsor.
234. Develops and maintain process SOPs and standards for managing the CRO-Sponsor relationship.
236. Develops technical components of Request for Proposal. Alternatively, develops the CRO's response to the Request for Proposal.
237. Evaluates proposals received from CROs or other vendors. Alternatively evaluates proposals in response to RFP.
240. Recognizes, communicates and documents scope changes in the delivery of CRO services.
241. Defines standards for deliverables and status reporting requirements, create timelines/milestones.
242. Oversees development of data management plan (including Data Handling Guidelines) and its implementation in a CRO final review and approval.
243. Provides day to day management of all CRO/Sponsor interaction activities.
Relational Databases
244. Understands the fundamental need for and uses of relational databases and communicate these concepts to others when discussing tasks, assignments or projects.
245. Executes basic data manipulations and data definition functions following specific oral or written instructions.
246. Demonstrates working knowledge and efficient use of the DBMS.
247. Exhibits increased understanding of relational databases and their functionality by discussing architecture, specific applications and performing specific operational routines.
248. Determines why a specific relational database is the product of choice for new applications, either in the conceptual or design stage, and supports the choice with detailed technical, operational, and business rationale, if required.
249. Troubleshoots system problems, resolve related issues, and recommend appropriate modifications.
250. Is considered one of the organization's subject matter experts regarding relational databases, based on the extent of knowledge and applications of the knowledge.
187. Informs team of database locking timelines/issues.
Clinical Database Design
036. Designs clinical database structures for data acquisition and data entry.
037. Implements, per design, clinical database structures for data acquisition and data entry.
038. Designs clinical database structures for data validation.
039. Defines content, structure and procedures for using a library of database modules.
040. Implements, per design, clinical database structures for data validation.
041. Designs clinical database structures for data analysis and reporting.
042. Implements, per design, clinical database structures for data analysis and reporting.
CRF Tracking and Inventory
043. Applies protocol/CRF schedules to populate CRF tracking tools, if they exist.
044. Creates tools to track and inventory CRFs.
045. Defines user requirements for integrated electronic tools to perform CRF tracking tasks.
046. Notifies data entry group of priorities.
047. Determines and reports anticipated vs. actual CRF receipts.
048. Routinely maintains tracking/inventory and identifies missing CRFs.
049. Tracks down and retrieves missing CRFs.
050. Identifies CRF flow issues and initiates steps to resolve.
051. Resolves issues with data flow in collaboration with the project team.
052. Develops and maintains process, SOPs and standards for CRF Tracking and Inventory control.
CRF Data Entry Process Discrepancy Resolution
053. Develops guidelines for data entry.
054. Resolves discrepancies and issues that arise during data entry that are not readily resolved by data entry staff, e.g. medical abbreviations and terminology, marginalia.
055. Understands the discrepancy resolution process (includes AE-subject data).
056. Compares the entered data to the original to arrive at proper verification.
057. Reviews and oversees routine verification activities to assure consistency and judgement.
058. Creates reports to track data entry process.
CRF Data Validation (e.g. data review, cleaning, query generation, applying data handling conventions)
059. Understands the data validation process and its importance.
060. Understands the interaction of data types across CRFs and visits to perform review where automated checking is inefficient.
061. Identifies areas of manual review where electronic checks are not effective.
062. Is able to apply thorough detailed review of CRF data routinely.
063. Initiates automated methods to minimize manual review.
064. Identifies tools and methods to improve or facilitate manual review process.
065. Evaluates and improves efficiency of the data validation, query, query resolution process.
066. Relates elements of protocol to defining data validation checks.
067. Defines content, structure and procedures for using a library of standard data validation procedures and queries.
068. Applies standard data validation techniques, software and guidelines to routine data cleaning activities.
069. Defines new requirements for data validation techniques, procedures, etc.
070. Defines data handling conventions.
071. Uses appropriate problem solving techniques to ensure that the precise data problem is identified and queried.
072. Defines standards for written queries and query process.
073. Develops standard query language.
074. Writes clear, concise queries.
075. Generates queries based on standard data cleaning practices.
076. Documents and maintains data validation process, SOPs and standards.
Safety Review
104. Identifies safety issues/trends for the study based on clearly defined guidelines and a review of all clinical trial data.
105. Understands safety profile of the drug under study and disease state of patients.
106. Defines guidelines for identifying safety issues/trends in collaboration with clinical.
107. Communicates safety trends to project team.
108. Develops and maintains process, SOPs and standards to compliance with regulations for reviewing and reporting SAE data.
109. Understands severity levels in AE data.
SAE Reconciliation
138. Understands the definition of serious adverse events.
139. Is able to identify SAEs in clinical data.
140. Develops and maintains SOPs process and standards for reconciling SAE data with other clinical trials data.
141. Understands the SAE reconciliation process.
142. Reconciles clinical databases' adverse events with serious adverse event reporting databases according to guidelines.
143. Documents the outcome of the reconciliation process clearly and consistently.
144. Creates automated tools/or ad-hoc reports to present information appropriate to reconciliation.
145. Relates different or similar medical terms/conditions in order to reconcile information presented in different text/coding terms from different systems.
146. Understands the data that SAEs are reconciled against and make decisions on what to query.
147. Performs and makes tactical decisions about the SAE reconciliation process.
Review of Final Data Tables or Graphs
209. Identifies inconsistent data points.
210. Understands algorithms for derivations, collapsing, imputation, and summarization of data.
213. Identifies outliers.
214. Handles and documents outliers.
Archiving Database and Associated Information
222. Understands procedures related to archiving.
223. Develops and maintains archiving process and standards SOPs.
226. Performs data archiving steps.
CRF Design
012. Relates protocol to CRF design and ensures that design supports data analysis and reporting requirements.
013. Creates effective/efficient new CRF designs from new data types that are defined by protocol.
014. Understands and applies widely accepted good CRF design techniques.
015. Collaborates with team members to assure all needs are met by the CRF design.
016. Identifies data collection that will require non-standard programming.
017. Is able to explain why a particular collection method is not appropriate if it isn't.
018. Defines content, structure and procedures for using a library of CRF design modules.
019. Ensures CRF design consistency across number of studies in a program.
020. Identifies and requests additions to standard metadata.
021. Creates annotated CRF.
022. Documents CRF completion guidelines and instructions.
023. Presents CRF completion instructions at investigator meetings.
024. Develops and documents the process, SOPS, and standards for CRF design, approval, and change control.
Query Resolution
077. Clearly understands the data problem identified.
078. Writes clear and concise query responses.
079. Applies corrections to database using appropriate QC.
080. Develops and maintains process, standards and SOPs for query resolution.
081. Applies sound judgement and decision making to evaluating responses and applying to database updates, documentation, etc.
Query Tracking
082. Develops and maintains process SOPs and standards for query tracking.
083. Creates tools to track and inventory queries.
084. Maintains tracking/inventory and identify outstanding queries.
085. Categorizes queries by age/site and regenerates if necessary.
086. Tracks down and retrieves outstanding queries.
087. Creates standard reports to efficiently identify outstanding queries, query types per site, etc.
088. Generates and interprets standard reports of query status, in support of standardized metrics.
089. Defines user requirements for integrated electronic tools for query linking and management.
090. Relates queries per site to additional training requirements at site to attempt to reduce query needs.
091. Relates queries to processes and activities (e.g. CRF design) requiring process improvements.
Database Updates
099. Follows up on query responses, errors identified in data cleaning by performing accurate database updates.
100. Reviews the updates of peers in terms of assuring accuracy/quality.
101. Documents database changes in the automated system audit trails and paper/electronic documentation.
102. Develops and maintains process, standards and SOPs for performing database updates.
103. Reviews audit trails, database change rates to assure staff expertise, extraordinary problems with CRF design, investigator site training, database screen design, etc.
Coding (AEs; Signs and Symptoms)
110. Understands medical terminology.
111. Utilizes available tools, systems and processes in support of the coding of medical terms.
112. Understands the structure of an electronic medical dictionary.
113. Understands what medical autoencoding is and how it works.
114. Possesses knowledge of algorithms that are applied to coding.
115. Can manually code adverse events, when/if required.
116. Familiar with all standard adverse event dictionaries, e.g. COSTART, MedDRA.
117. Familiar with company-specific dictionaries and code lists.
118. Defines company-specific dictionaries and code lists.
119. Develops and maintains process SOPs and standards for coding adverse events and symptoms.
120. Creates an ad hoc listing of coded adverse events for clinical review of pointings/mappings.
121. Reviews and approve a list of coded terms.
122. Determines if the correct preferred term has been applied.
123. Defines autoencoding algorithms.
124. Comprehends coding algorithms and assures that the correct algorithm has been applied.
125. Understands the structure of a dictionary and manipulates it, if necessary.
126. Identifies all standard AE dictionaries and understand the differences between them.
Coding Medications
127. Understands what medication coding is and why it is important.
128. Understands drugs dictionary drug classes and what they mean.
129. Determines if the correct code has been applied.
130. Creates an ad hoc listing of medications.
131. Can manually encode medication data, when/if required.
132. Understands algorithms and how they are applied to coding.
133. Identifies all standard drug dictionaries, e.g. WHOMED, BNF.
134. Develops and maintains SOPs process and standards for coding medications.
135. Creates ad hoc listings of medications for clinical review of pointings/mappings.
136. Defines drug autoencoding algorithms.
137. Understands the structure of the medication dictionary.
Database Quality Control Audits
188. Understands the data handling process, tools and data management plan.
189. Understands and applies quality acceptance criteria.
190. Distinguishes critical from non-critical errors.
191. Performs database audit and generates report per guidelines.
192. Documents database QC performed.
193. Develops and maintains process and standard SOPs relevant to database audits.
194. Established quality criteria and quality error rates acceptance limits.
195. Evaluates data points that should be audited.
196. Establishes timelines to perform an audit and oversees activities of audit team.
197. Identifies root cause of errors in order to recommend change in process/technology to assure the error doesn't occur again (continuous improvement).
198. Ensures adequate preparation for internal and external database and data management audits, can respond knowledgeably and confidently to issues or questions that arise during audits.
199. Ensures scope of audits include all potential sources of data errors.
200. Ensures that sampling audit techniques are statistically valid and support decisions made about data.
201. Applies sound judgement on handling audit findings.
202. Identifies inconsistent data points.
203. Understands algorithms for derivations, collapsing, and imputation.
204. Defines requirements for data listings.
205. Identifies trends in data.
206. Identifies outliers.
207. Deleted from capabilities.
208. Handles and documents outliers.
Review of Final Reports
217. Understands Clinical Study Report Guidelines.
218. Understands the Clinical Study Report Outline.
221. Understands the following: ISE- Integrated Summary of Effectiveness, ISS- Integrated Summary of Safety Information.
Information Technology
252. Conducts user testing of systems and applications per written specifications.
253. Develops and approves user acceptance test specifications and test results.

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