Clin Infotech

CDM Interview questions:
1. CRF designing? How to create visits forms and code lists?
Case Report From is electronic document used by investigator to record the all the protocol required information to be reported to the regulatory agencies.
Pre requisites for CRF design 
Approved Protocol
Mock up CRF 
CRF design request form 
Once CRF preparation is over arrange the forms in study visits/ study events according to the time and events table.
Code List: A collection of code-label pairs that gather together the entry choices for an item. A code-label pair consists of a single code (the value that is used for analysis) and a label (the value that is visible to users).

2. What are rules? Types of rules? How to create global conditions & Rule writing?
Two classes of rules are there

Data-entry (Add entry) rule—a rule that checks whether data is valid or that sets the value of an item based on a calculation. You can create a data-entry rule for study designs, study elements, study events, forms, and items.

Workflow rules and global conditions

• Workflow rule—A logical construct that tests data values to determine the study element, study event, or form to which a subject progresses next.
You can create a workflow rule for a study element, study event, or form only.

• Global condition—A logical construct that, when applied to a study object, determines whether the study object will appear for a particular subject.
Types of rules:
Intrinsic rule (Range checks, ex VS)
Constraint rule (other than range checks, ex : DOV)
Calculation rule (Ex: AGE Calculation, BMI calculation)
Rule writing:
We can write rules at study, element, event, forms and item level
Go rule tab – new rule – Quick start – properties – preconditions – expression – action

3. What are special forms, monitoring forms and special items?

Special Forms
In InFrom application certain forms require special design requirements to make sure that thisr data is correctly handled in InFrom
Patient identification 
Study completion

Special Items
Special InFrom items are required for some forms. We can include special InFrom items in regular forms:
DOV: purpose of DOV in InFrom application is captures the visit date for any visit 
Randomization: purpose of Randomization in InFrom application is it holds a sequence and drug kit number generated by InFrom randomization processing

key items: it is a repeating form

Monitoring forms: Regulatory documents and visit reports, which are monitoring forms, are custom forms used by monitors when they visit sites. You are not required to create monitoring forms.
Visit report form: can be used by CRA to report finding from visit report form is not repeating from but it contains repeating sections.

Regulatory documents: A form that a CRA uses to record whether required regulatory documentation, such as the study protocol, IRB approvals, and electronic signature reporting documentation, is available and up to date. A regulatory document form is not repeating by default, but you can mark it as repeating.
During deployment, a study event is created for each monitoring form

4. Is rule is part of object? True or false?
Yes it is true. A data entry rule is a part of the study object and not a separate component that is attached to the study object. Rules can a part of study design, element, events, forms and items

5. How to create logical schemas & what is its use?
6. How to copy forms? What is the role of with children & without children?
When you copy a study object, all of its child study objects are copied with it.
Link: The new study object retains a link to the original. If either the original or the new study object is modified, the other study object is modified, and all other reference copies of it within the study are also modified.
All child study objects are copied with links to the original study objects

With children: The new study object has no link to the original. If either the original or the new study object is modified, the other study object is not affected.
All child study objects are also copied and do not retain links to the original study objects. Therefore, a change to either the original or new child study objects does not affect the other.

Without children: The new study object has no link to the original. If either the original or the new study object is modified, the other study object is not affected.
All child study objects are copied with links to the original study objects. Therefore, if either an original or a new child study object is modified, the other study object is modified, and all other reference copies of it within the study are also modified.
7. What is implicit and explicit locking?
Implicit lock
A type of lock used when you edit a study object. An implicit lock is automatically applied when you select or open a study object and is automatically released when you close or save a study object.

Explicit lock
A lock that you request and that does not expire with time. It is applied to rule when you explicit lock it and is released only when you unlock the rule. You might request a lock if you plan to work on a rule for an extended period of time.

8. What are dependencies? Examples?
Forms or visits are inter depended on each other.
In the following example, a global condition checks whether the subject is female, based on the Gender item in the Demographics form. If the condition is true, the Pregnancy form is presented

9. What are compound item, how to create and its use?
An item that has one or more child items that can have different data types. 
Example: Blood pressure. It can be prepared in form level and item level.

10. What is publishing & unpublishing, what will happen if we publish an item?

The action that makes a study object created in a library available to other users.

The action that makes a study objects in a library no longer available to other users.

11. What is categorization?
You can categorize a study object with keywords and categories to facilitate searching for study objects in the Libraries Browser. You must save a study object before categorizing it.
In the following example, cardiology appears as a category. The categories of heart, arteries, and veins appear below cardiology, and cardiology also appears below the therapeutic area category. 
You can search for a study object that has been categorized with cardiology:
No matter where cardiology appears in the Categories tree.
When cardiology appears only under therapeutic area.
When cardiology appears with arteries, heart, and veins below it.

12. What is rule template & how to create a template?
A function that is defined on a study object, study object template, or study object type and can be used as the expression clause of a rule.

13. What is collaboration note?
In the Central Designer application, users with different roles and specialties can work together to create, validate, and deploy a study. For example, some users specialize in understanding clinical issues and protocols, while others focus on technical details regarding study implementation.
Collaboration note: A note that you attach to any study object.

14. What is task? What is standard and translation task?
A task is a request that you attach to a study object (a study, study element, study event, form, or item). A task is similar to a collaboration note except that you assign a task to an individual or to a whole study team. In a task, you can include detailed information and specify a due date and priority. You can format the text of a task and attach a file to it.
Used for all non-translation tasks assigned to an individual or team. 
When you create a standard task, you can override the default assignment.
Used for tasks that request translation of a study object into one or more languages.
When you create a translation task, you choose the language into which the study object must be translated.

15. What are the control types?
Date and Time
Compound item 
Text item
Float Item
Yes or no item 
Drop down

16. What is central design?

e CRF preparation
DVS preparation 
UAT testing 
QC testing

17. What is a form? Types of forms?
A form is a container for one or more items. A form can contain multiple sections and supports multiple layouts. A section is a from embedded within a form

Repeating form (holds multiple instances of the same set of data)

Common form (same data is visible in all study events that contain the form)

Associated forms (Two repeating forms in the same study event, the user can access the data from either form)

Dynamic form (Pregnancy)

18. In date and time control item, we enter the subject with time in hour, where should we use it?
We can find time in hour in item properties window (date and time field)

19. If we do not want pregnancy from in screening we need that form only in visit 1, where should we right the program?
No need of assigning condition on pregnancy form in screening visit.

20. If there are 50 items in dropdown list, shall we type & enter all the 50 items? Or is there any alternate method for entering?

No short cut. We need to enter manually

21. How import & export the study objects?
22. What is base line validation?
23. How to mark an item as type- it’s modifying & publishing?
24. How to add collaboration note & various types?
25. What is the difference between dynamics & global conditions?

1. What is CDM?
Clinical data management is the collection, integration and validation of clinical trial data

2. What is CDMS?
Clinical Data Management system CDMS is a tool used in clinical research to ensure that the data collected in the course of clinical trial is 
The trial data which is collected at the investigator site is stored in CDMS
CDMS examples : 
Oracle InForm
Oracle Clinical

3. What is DMP?
Data Management Plan (DMP) is a critical element in conducting a successful clinical study or trial. The DMP is usually very general during the protocol development stage, but it should become very detailed immediately before study initiation.
A typical DMP provides detailed descriptions of how the following areas will be addressed during the clinical trial:
• CRF Design & Processing
• DVS preparation
• Programming for edit checks
• QC testing
• UAT testing
• Data Entry
• Validation and Query Generation
• Query Management
• SAE handling
• Coding
• Filing
• Audits

4. What is GCDMP?
Society for Clinical Data Management (SCDM) publishes the Good Clinical Data Management Practices (GCDMP) guidelines, a document providing the standards of good practice within CDM. GCDMP was initially published in September 2000 and has undergone several revisions thereafter. The July 2009 version is the currently followed GCDMP document. GCDMP provides guidance on the accepted practices in CDM that are consistent with regulatory practices. Addressed in 20 chapters, it covers the CDM process by highlighting the minimum standards and best practices.

GCDMP meant for:
• Data managers
• Data processors
• Statisticians
• Site personnel
• Clinical professionals
• Compliance auditors
• Regulatory affairs personnel
• All clinical research professionals making decisions regarding or using the clinical trial data

5. Why 21 CRF part 11 is important in CDM?
21 CRF part 11 is important in CDM because it describes about Electronic Records and electronic Signatures

6. What is the CDM Process?
The CDM process, like a clinical trial, begins with the end in mind. This means that the whole process is designed keeping the deliverable in view. As a clinical trial is designed to answer the research question, the CDM process is designed to deliver an error-free, valid, and statistically sound database. To meet this objective, the CDM process starts early, even before the finalization of the study protocol.

Review and finalization of study documents
Database designing
Data collection
CRF tracking
Data entry
Data validation
Discrepancy management
Medical coding
Database locking
7. What are the Roles and Responsibilities in CDM?
In a CDM team, different roles and responsibilities are attributed to the team members. The list of roles given below can be considered as minimum requirements for a CDM team:
• Data Manager
• Database Programmer/Designer
• Medical Coder
• Clinical Data Coordinator
• Quality Control Associate
• Data Entry Associate
8. What are the roles & responsibilities of clinical data manager?
The data manager is responsible for supervising the entire CDM process. 
Preparation of the DMP
Approval of the CDM procedures and all internal documents related to CDM activities. 
Controlling and allocating the database access to team members 
9. What are the roles & responsibilities of clinical data co-coordinator?
The clinical data coordinator designs the CRF, prepares the CRF filling instructions, and is responsible for developing the DVP and discrepancy management. All other CDM-related documents, checklists, and guideline documents are prepared by the clinical data coordinator.

10. What are the roles & responsibilities of clinical data base programmer?
The database programmer/designer performs the CRF annotation, creates the study database, and programs the edit checks for data validation. He/she is also responsible for designing of data entry screens in the database and validating the edit checks with dummy data.

11. What are the roles & responsibilities of quality control associate?
The quality control associate checks the accuracy of data entry and conducts data audits. Sometimes, there is a separate quality assurance person to conduct the audit on the data entered. Additionally, the quality control associate verifies the documentation pertaining to the procedures being followed.

12. What is e -CRF?
Electronic case report form.(Study information directly entered into computer).

13. What is CRF and what is its importance?
CRF stands for Case Report/Record Form. CRF is perhaps, the most important document after the protocol since all the clinical trial data is collected through the CRF

14. What is Annotated CRF?
An annotated CRF is a CRF in which the variable names are written next to the spaces provided for the investigator. It serves as a link between the database/data sets and the questions on the CRF.

15. What is CRF tracking? – (CRF tracking is only applicable in paper based studies)?

The entries made in the CRF will be monitored by the Clinical Research Associate (CRA) for completeness and filled up CRFs are retrieved and handed over to the CDM team. The CDM team will track the retrieved CRFs and maintain their record. CRFs are tracked for missing pages and illegible data manually to assure that the data are not lost. In case of missing or illegible data, a clarification is obtained from the investigator and the issue is resolved.

16. What is database? Explain how to design a data base?
A data base is a simply a structured set of data means collection of rows and columns. Data from a clinical trial will be collected and stored in the CDMS.
Databases are the clinical software applications, which are built to facilitate the CDM tasks to carry out multiple studies. Generally, these tools have built-in compliance with regulatory requirements and are easy to use. “System validation” is conducted to ensure data security, during which system specifications, user requirements, and regulatory compliance are evaluated before implementation. Study details like objectives, intervals, visits, investigators, sites, and patients are defined in the database and CRF layouts are designed for data entry. These entry screens are tested with dummy data before moving them to the real data capture.
17. What is data entry? What are Data Entry types?
Data entry is a process of entering/transferring data from case report form to the clinical data management system (CDMS)
• Single data entry
• Double data entry

18. What are Double Data Entry & its importance?
This method involves two people entering the same CRF data onto the database independently of each other. Depending on the software used, the data may be entered twice onto the database on two separate files, which are then compared by the system for accuracy. If the two entries do not match this would be flagged up by the database. Alternatively when the second data entry person enters the data, if it differs from that entered by the first person, a message immediately appears on screen and the original data can be checked. This method depends on the availability of a technically capable database. DDE is important because it helps in reducing the discrepancies that arise due to errors in data entry.

19. What is Single Data Entry with Control Checks? 
This method may be more suitable for smaller single centre studies with less staff available for data entry and/or less sophisticated database software. Once the data has been entered, a visual Check can be done between what is recorded on the paper CRF, and what was entered on screen. (Note: only applicable in paper based studies)

20. What is User Acceptance Testing?
UTA is nothing but of comparing annotated view of PDF file and oracle InForm 
Database is the exact replica of the CRF pages. Once the database design is over, then Data Management tests the database for User Acceptance, which is called User Acceptance Testing.
[User Acceptance Testing is often the final step before rolling out the application. Usually the end users who will be using the applications test the application before ‘accepting’ the application. This type of testing gives the end users the confidence that the application being delivered to them meets their requirements. This testing also helps nail bugs related to usability of the application.
The steps taken for User Acceptance Testing typically involve one or more of the following:
• User Acceptance Test (UAT) Planning
• Designing UA Test Cases
• Selecting a Team that would execute the (UAT) Test Cases
• Executing Test Cases
• Documenting the Defects found during UAT.6) Resolving the issues/Bug Fixing
• Sign Off]

21. What is Discrepancy?
Discrepancy management is a process of cleaning subject data in the clinical data management system, it includes manual checks and programmed checks. Discrepancy management is the most critical activity in the CDM process. Being the vital activity in cleaning up the data, utmost attention must be observed while handling the discrepancies.

22. What is discrepancy management?

As a result of batch validation, the discrepancies that arise in the database are managed by the discrepancy management team.
1. Discrepancies are resolved through the Data Clarification Form (DCF) or the Data Query Form (DQF).
2. DCF is generated and sent to the site (investigator) for clarification.
3. After the corrected values are received from the investigator as a response to the DCF, the responses are updated in the database
4. After ensuring that the data is error free, the database is locked to avoid further unauthorized Modifications
(Note: data cleaning, data processing / data validation/ data management/query management/discrepancy management are synonyms to each other)

23. Data queries?
Where data entered does not pass validation rules then a data query may be issued to the investigative site where the clinical trial is conducted to request clarification of the entry. Data queries must not be leading (i.e. they must not suggest the correction that should be made). For electronic CRFs only the site staff with appropriate access may modify data entries. For paper CRFs, the clinical data manager applies the data query response to the database and a copy of the data query is retained at the investigative site.
1. Automated queries : closed by CDM Manager 
2. Manual queries 
24. What is reconciliation and explain SAE reconciliation?

Reconciliation is the comparison of key safety data variables between the clinical trials database and the safety database (CDMS and sponsor PV department in-house database). Reconciliation is performed to ensure that events residing in both systems are consistent.

[What happens, once patient experiences any serious adverse event at investigational site then the investigator is supposed to fill SAE form and send it to the drug safety department of the company, and there the drug safety department will enter that SAE form in their safety database. At the same time investigator have to mention that serious adverse event in the CRF of that patient and then send it to the clinical data management department.
CDM role is to merge or reconciliate the safety database and clinical database of that particular patient in the oracle clinical data base system].

1. Reconciliation of SAEs captured during the conduct of clinical research trials and SAEs recorded in the Safety Database will occur several times during the lifecycle (the conduct) of the clinical research trial. 
2. Timing and number of the reconciliation cycles will be determined by the frequency of data received the scheduling of safety updates and the timing of interim and final reports to regulatory authorities on serious adverse event findings.
3. The capture of SAEs in both the clinical trials database and the safety database should be standardized with regard to data captured and coding of terms (e.g., event description, start and stop date, relation to study drug, verbatim term coding, etc.). 
4. All information (data and metadata elements) to be reconciled during this procedure shall be identified and documented in the study plan before the first patient is enrolled in the clinical research protocol.
5. A cut-off point will be identified in the study plan, after which, no SAEs will be added to the clinical research database, even if the safety database is updated. 
6. Changes to either database, as a result of reconciliation activities, will be made in a timely manner to expedite clinical study closure activities and/or safety reporting requirements.
7. Local QA formally conducts a review of the reconciliation results for accuracy


Study Coordinator

• Work with the Drug Safety Officer and the Clinical Research Study Team to reconcile SAEs captured in the clinical data management application with SAEs captured and recorded in the Safety Database.
• Make the necessary changes and/or updates to the clinical data management application.

Drug Safety Officer
• Assist in reconciling SAEs in line with this SOP
• Make the necessary changes and/or updates to the Safety
Clinical Study Team
• Provide the necessary clinical information or interpretation input on SAEs captured during the conduct of the clinical research trial, including input on coding of events
Local QA

• Conduct a formal review of the reconciliation processes and performs a quality check on updates to the databases.

25. What is lab reconciliation?
Reconciliation of lab data should be done during electronic loading of lb data (batch loading). It is general practice in central labs. At this stage lab data in lab data base has to be checked against general data base (CDM) to find out any discrepancies across both data bases.

26. What is SEC?
(Note: only applicable in paper based studies)
Self-Evident Corrections (SEC). In discrepancy management, discrepancies are either flagged to the investigator or closed in house by self evident corrections (SEC’S) without sending DCF to the site. The most common SEC’s are obvious spelling errors

27. What is DCF? 
(Not: only applicable in paper based studies)
Data Clarification Form or Data Query Form is a questionnaire specifically used in clinical research. The DCF is the primary data clarification tool from the trial sponsor or Contract Research Organization (CRO) towards the investigator to clarify discrepancies and ask the investigator for clarification. The DCF is part of the data validation process in a clinical trial.

At a minimum, the following metrics must be tracked for DCFs:

• Total number generated/sent
• Total number returned
• Total number resolved
• Number of DCFs outstanding greater that “x” days.

28. Who will update DCF’s?
Clinical data manager will raise DCF.

29. What is DCF printing, tracking and updating?
For discrepancies that require clarifications from the investigator, DCFs will be sent to the site. The CDM tools help in the creation and printing of DCFs. Investigators will write the resolution or explain the circumstances that led to the discrepancy in data. When a resolution is provided by the investigator, the same will be updated in the database. In case of e-CRFs, the investigator can access the discrepancies flagged to him and will be able to provide the resolutions online.

30. What is EDC?
An Electronic Data Capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices. EDC solutions are widely adopted by pharmaceutical companies and clinical research organizations (CRO). 
a graphical user interface component for data entry
a validation component to check user data
a reporting tool for analysis of the collected data

31. What are the advantages of EDC over paper based studies?
EDC supports standardization, which can help set up studies faster. 
EDC can help clean and lock data faster than traditional paper CRF systems. 
Now a day’s EDC acceptance is strong; there are very few instances where users have gone back to paper based data collection
EDC reduces time for study startup, database cleanup, and database lock, leaving more time for statistical analyses, final study reports, regulatory submissions, and, ultimately, reduced time to market launch
32. What is RDC?
Remote Data Capture. RDC involves the data entry through networked systems like internet

33. What is RDE?
Remote data entry

34. Define closed systems?
Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system

(It is related to systems passwords and security. E are using closed systems)

35. What is SDV? When is it required?
Source Data Verification and it is required during audit trails, discrepancy management

36. What is Batch validation? 
(Note: only applicable in paper based studies)
Scope – Batch validation is able to read all data within a subject regardless of visit. In addition, some are also capable of checking across patients. EDC systems with online validation also generally manage to read all data for a subject, but do not permit reading across subjects.

37. What is Data Review?
Data cleanup does not have to impact a project’s momentum, as CPDM supports both manual and computerized review, before, during, or after data entry. You can maintain a library of standard questions to speed Data Resolution Form (DRF) preparation and to promote consistency. Users can customize and generate DRFs for printing, faxing or email, as well as to track each DRF and question. When DRFs are returned, data processing personnel scan or type in a pre-assigned “page key,” which immediately brings up the record for correction, saves the amended record, updates audit trail information, automatically changes the record status, and, if all the questions for that page are resolved, updates the page status. Thus, each correction to the database is made in a single action with a complete audit trail.

38. Scanning & indexing? 
(Note: only applicable in paper based studies)
In order to significantly improve the standard data review process of paper CRFs, Metronomia has developed scan Trace – a browser-based online application to retrieve and review CRFs, queries and data. From wherever they are, CRAs, data managers or medical reviewers can access scan Trace with flexible user rights, over a secured website, so as easily to select CRF images, access related queries, create PDF reports or communicate on CRF related issues.
Indexing means arrangement of CRF forms in a systematic way in to the corresponding visits /events. Example what are the forms should be present in screening, visit 1 and visit 2 etc. 
39. Derivation process?
Perform calculations on collected data to derive values ex: convert values to alternate units or complete a value from other data (patient age from birth date and visit date). Auto population is called derivation. We will come cross ith this term in AEID (adverse event ID). Whenever we created a new form then the site ill auto populate the number of forms entered for that particular subject in different visits.

40. What is medical coding?
During a multi centric trial, there tends to be a lot of variation in reporting AE. Medical coding is helpful in bringing uniformity in AE reporting. The medical coding for a study is done as per the project specific protocol requirement. 
There are two types of coding 
Automatic coding: The items entered in the database will be pushed to the central coding database where if the term or the medication is entered exactly then it directly codes to all coded values. It occurs in both AE & MH forms.
Manual coding: the items entered ill not be as per standard of coding dictionary so then item ill not map all the coded values, so we need to code the values manually. But before coding medical conditions or medications the medical coder will raise the queries to clarification about the term. He will raise the queries hen the below conditions occurs
• Term is illegible
• Term is partial
• Term is misspelled
• Term is contractor
• Term is not brand drug 
Then site will respond to the medical coder queries and ill answer to the MC.

The dictionaries used for the study are 
1. AE: MedDra (Medical Dictionary for Regulatory Activities)
WHOART (WHO Adverse reporting terminology. Used in AE coding)

2. Medications: WHODD (World Health Organization drug dictionary)
3. ICD9CM : International classification for diseases – used for diseases

41. Who are the vendors for EDC?
42. What are the data entry guidelines? 
43. What are the data cleaning guidelines?
44. What are the guidelines used in CDM?
45. What is data fax?
46. What is in house data reviews?
47. What is data base closure?
48. How do you change the header information?
49. What is CSR?
50. What is CTC grading?
51. Quality control in CDM activities relevant to data base?