ClinPlus Data Management - Frequently Asked Questions

33 Questions to Ask Before Buying Data Management Software

While choosing the wrong product is never a good idea, when it comes to clinical trials software, the wrong product could be disastrous for your company. We've made a genuine, good will effort to compile the most important factors that should be considered before buying. Some questions are fairly basic, but most are insightful and thought provoking. If you think of additional questions that should be asked by others in the decision mode, please pass them on to us and we'll include in updated editions.

Q1. Is your software 21CRF Part 11 compliant?

Reason for asking:
21 CRF Part 11 are FDA regulations to which all clinical trials software must adhere.

DZS Answer:
Yes, DZS continues to strive to meet all applicable FDA regulations.

Q2. How long does it take to install your system?

Reason for asking: It stands to reason that the longer it takes to install a system, the longer it takes for you to be up and running. Furthermore, a long and complex installation process may indicate an excessive future maintenance requirement.

DZS Answer:
Our Data Management software is installed in about 15 minutes using Wise Installer®, an intuitive installation utility. Installation qualification and system configuration may take a few hours.  User acceptance validation may take 1-2 weeks using the available ClinPlus Validation Package.

Q3. How long does it take to be trained on your system?

Reason for asking: As in the above question, the longer it takes to learn a software system, the longer it takes to become operational. Furthermore, the longer the training period, more complex the system and the more likely mistakes are to occur. Lastly, users are less likely to retain information from drawn out sessions.

DZS Answer:
Training is conducted over a two day period. All users need not attend all sections if topics are not related to their job functions.

Q4. How long does it take to set up a new protocol on your system?

Reason for asking: Although data management tasks such as data entry, data review and coding may proceed concurrently, none may begin until the study is setup properly in the data management system. It is extremely important that this be an efficient streamlined process if time lines are to be met.

DZS Answer:
Of course the time required to set up a study will vary depending on number of CRF pages, complexity of the pages, number of required edit checks, etc. ClinPlus Data Management incorporates tools such as protocol modeling, global library support for data structures, screens, etc. and an intuitive, flexible approach to study setup. Generally, each unique data domain/screen can be defined in 3-4 hours.  Our clients report that most studies are set up within 3 to 10 days.

Q5. Does your software provide true record level locking?

Reason for asking: This is important if you expect simultaneous, multiple update access to the same record.

DZS Answer: 
True record level locking is provided via SAS/Share. 

Q6. Does your software support EDC studies via the Internet, Intranet or VPN?

Reason for asking: This should allow real-time access to data, summary reports and query information and should support telecommuting and is a must if you plan to implement EDC studies. Remote capability is a valuable attribute when you realize the advantages of expediting data entry from the site and then being able to access it from wherever you may be.

DZS Answer:
Remote access is supported via Citrix.  Features such as role-based menus, site-based security, electronic signatures and monitoring functions are included to support EDC.  Since the same software is used for paper and EDC, studies may be entered remotely at some sites while paper CRFs are collected at other sites.

Q7. What are the security features of your system?

Reason for asking:
You should be able to limit access by users for their designated function. Files should be protected from unauthorized alteration. EDC systems will require more extensive security features.

DZS Answer:
ClinPlus Data Management includes a robust role-based security system to support extremely flexible security models.  Features include definition of users, groups and tasks, limiting sites to their own data, controlling data access down to the field level, hours of access and control of time-outs, lock-outs and password complexity and enforcement.  Citrix will add an additional level of security for EDC studies.  

Q8. Does your software require specialized hardware?

Reason for asking:
Both minimum and recommended requirements should be obtained. The simpler the requirements the less costly.

DZS Answer:
The hardware requirements for the ClinPlus DM system are the same as SAS's. Generally, if you are able to run SAS then you will be able support ClinPlus.

Q9. Do we need to have programmers on staff to support your software?

Reason for asking:
Be sure to find out in what situations or phases of study setup where staff programmers are needed. Then inquire about what skill sets are required. The fewer the programmers and the less advanced they need to be, the more likely the software is better designed and easier to use and modify.

DZS Answer: 
Although programming is not required when designing data entry screens, ClinPlus does include "events" where custom code may be inserted.  This allows users to define data entry screens to work exactly as required for their unique application.  SAS SCL programming is used to support this feature (many examples can be found on our User Forum section under Support). 

 Also, Base SAS programming is required for writing edit check programs and any custom reports that are required. No DBAs are required to maintain system data.

Q10. What kind of on-site support staff will we need with your software?

Reason for asking:
On site support includes IT support, DBAs, programmers, writers etc. You should also know what skill sets are required. The more support, the more demanding the skill sets requirements, the more expensive the system is to operate.

DZS Answer:
Typically the data managers administer the ClinPlus system. Because ClinPlus is purely SAS, there is little need for IT intervention other than hardware and data backup support. A SAS programmer or two may be needed primarily aiding in screen design and writing edit check programs.

Q11. What kind of technical support do you provide?

Reason for asking:
The quality of technical support is determined by the proficiency of the support staff, the hours that the support is available and the average response time to queries.

DZS Answer:
DZS technical support and customer service has always received the highest praises from our clients. Because so few technical support calls are received, calls are routed directly to a developer who has intimate knowledge of the system. Most issues are addressed during the first call. DZS provides technical support during regular east coast business hours or clients can arrange for extended coverage.

Q12. Will I receive upgrades and enhancements? How often? How much will they cost?

Reason for asking:
While you should expect to receive periodic upgrades and service releases, when those updates are too-frequent "patches", it may be an indication of software instability. Such instability can result in a validation nightmare. It is advisable that you inquire as to the release history of the system. The cost of upgrades should also be considered and added to the overall investment cost.

DZS Answer:
ClinPlus Data Management has been evolving for nearly 20 years with incremental updates including feature and performance enhancements and bug fixes. Incremental releases have averaged 1 per year. If serious problems are identified then a service release is provided immediately. This has occurred less than 10 times in the entire history of the software. DZS is dedicated to the continued development of the ClinPlus software to better serve our clients and to react to the ever-changing technologies and regulations.

Q13. What aspects of the clinical trial process does your software address?

Reason for asking:
Most clinical trials software programs are quite specific in their application. Be sure to determine exactly what applications are supplied as well as what other integrated modules are available. Although you many not recognize a current need for a specific capability, it is advisable that the software you choose be able to smoothly integrate with the full scope of clinical trials software requirements.

DZS Answer:
The ClinPlus Data Management product supports CRF tracking, data entry and data review with additional features that support EDC capabilities, import/export and a customizable report writer.   Also available are ClinPlus Coding that supports auto and manual coding of adverse events and drugs, ClinPlus CTMS for your clinical trial management needs and ClinPlus Report for the production of NDA quality tables and listings.
DZS Software Solutions provides the broadest suite of software available for clinical trial support.

Q14. Is your software fully validated?

Reason for asking:
If the software in not fully validated, neither is the data it will generate. Software validation is a key requirement of data submitted to the FDA.

DZS Answer:
DZS follows strict SOPs written to satisfy FDA and industry regulations and guidelines. No ClinPlus software is released until it has been fully validated.

Q15. Are validation documents available to me?

Reason for asking:
You are urged to conduct a vendor audit before investing in any clinical trials software. If you are audited by a client or regulatory agency, your software vendor should be able to produce a well organized complete validation report with supporting documentation and assist you with the audit.

DZS Answer:
Yes. A copy of the validation summary may be requested and all supporting documentation will be made available to you during an audit. DZS personnel are also available to assist in an audit.

Q16. Do you provide a test plan?

Reason for asking:
This is important if your SOPs require that you validate the software in your environment. A comprehensive test plan may take many weeks to write yourself.

DZS Answer:
A Validation Package is available for purchase.

Q17. How does your software handle mid-study changes?

Reason for asking:
On occasion, changes to the study need to be made because of data revelations or new parameters. Such changes may include altering data structures, modifying data entry screen, and accommodating new or removing obsolete CRFs. Find out about the complexity of making these changes and the required downtime, as these will impact the study timeline.

DZS Answer:
Mid-study changes are easily made using ClinPlus Data Management. Data set structures are changed simply by re-entering parameters (variable name, length, label, etc.) or adding or removing variables in the same window that was used to originally define the structure. Screen changes are also easily made and CRF page definitions can be added, removed or made obsolete at any time in minutes. Study downtime is minimal.  All changes to data structures are recorded in an audit trail.

Q18. Does your software allow for multiple-technologies, including Internet and paper based?

Reason for asking:
Data can be entered via the Internet at some sites while being paper based at others. If your studies call for data to be collected on CRFs while queries are to be resolved via the internet, such a capability would represent time savings as well as a reduced error rate.

DZS Answer:
With ClinPlus Data Management, data can be double-key entered in-house from paper CRFs and remotely via the internet/intranet into the same SAS data base. Or, data queries can be issued and resolved remotely for a study using paper CRFs. Also, the import utility can be used to support OCR of FAX input.

Q19. What audit trails does your software provide?

Reason for asking:
FDA regulations require all changes to data be audited. Audit trails may also provide additional benefits such as performance tracking, fraud detection and historical reference.

DZS Answer:
Several audit trails are maintained by the ClinPlus Data Management system including changes to verified data, differences between 1st and 2nd key data entry, changes to data structures and SAS formats. 

Q20. Does your software have roll back capabilities?

Reason for asking:
Rollback is important when one step in a multi-stepped batch process fails and your database needs to be returned to its pre-processing state. Find out if processes exist where roll back capabilities may be used.

DZS Answer:
No. ClinPlus does not use multi-stepped batch processes to update data and DZS's clients have never had the occasion or need to roll back. Backup tapes provide the necessary peace of mind.  However, certain actions such as data import and the batch edit check process do have features that mimic a roll back.

Q21. What reports can be generated with your software?

Reason for asking:
Ask about tracking, inventory, summary, coding, query and data listings. The report generator should be flexible enough to provide sorting, sub-setting and other options, and it should allow for adding custom reports.

DZS Answer:
ClinPlus Data Management includes a wide array of reports for CRF tracking, inventory, performance, query and data listings. Naturally we could not anticipate all reporting needs. But since all data are stored in SAS data sets, writing custom reports is a simple task for a SAS programmer.  Users may download the source code of all included reports for easy modification.  Or, for sophisticated reports, we offer our ClinPlus Report software.

Q22. Does your software offer maintenance and reusability of global data structures, data entry screens, etc.?

Reason for asking:
Maintenance and reusability of global data structures and data entry screens can greatly reduce study setup time and help enforce consistency. The software should also have the option to deviate from global standards.

DZS Answer:
ClinPlus Data Management allows you to maintain libraries of standard variable definitions, data set structures, screens, page definitions, edit check programs, etc. These can be copied from the libraries (or any other study) and modified as needed.

Q23. How are diagnostic programs (computerized edit checks) written and managed?

Reason for asking:
Find out in what language diagnostic programs are written. Next, you need to be sure that the required skill sets for writing and executing these edit checks exist in your staff. You also need to find out how long these diagnostics take to execute.

DZS Answer:
Diagnostic or edit check programs are written in SAS and are executed against the production database upon request.

Q24. How are query forms printed?

Reason for asking:
Properly designed query forms should allow you to customize them as needed. They should also be able to be faxed, e-mailed and accessed on line.

DZS Answer:
Query forms are defined using Microsoft Word templates. These may be study or client specific and may include a draft and final templates.  Templates are defined and modified using Microsoft Word where bookmarks are used as data element links.  No programming is required.  Forms may be printed, faxed or emailed directly from ClinPlus DM.    

Q25. How are database changes made when resolving queries?

Reason for asking:
Find out what steps are required to resolve a query and change the database. This process should be straightforward.

DZS Answer:
In ClinPlus Data Management, when queries are returned, the user retrieves the query from the database; links directly to the queried record for update and closes the query. The query ID is recorded in the audit trail to record that this change was made as a result of this query. 

If a response to a query is not satisfactory then you may issue a re-query.

Q26. How are queries tracked?

Reason for asking:
The tracking reports should be available to identify the status of all queries by site and to alert you if not resolved in a timely manner

DZS Answer:
Queries are tracked using a combination of status codes and user defined levels to allow detailed tracking of queries through you unique workflow. The Query Management module provides access to all queries at every stage of the process.  ClinPlus Data Management includes several reports to track queries including a summary, a detailed and an aging report. These can be printed on all or any subset of data.

Q27. What modes of data entry do you support?

Reason for asking:
Virtually all data management software offers "double-key" data entry. This is a process where one DE clerk enters data (1st key entry) then the same data is re-entered by a different DE clerk (2nd key entry). The two entries are then compared and differences are resolved. This process may be performed by a third person (this is considered "heads-down" data entry since the 2nd key clerk does not need to respond to data differences) or it may occur during the 2nd key entry (on-line verification). Some believe the "heads-down" method is more efficient because DE clerks can work uninterrupted and more experienced staff can better resolve differences. Others believe on-line verification to be more efficient because it eliminates the additional compare process therefore eliminating the need to maintain two versions of the same data. A well-designed system should provide the best of both worlds, the ability to perform on-line verification while providing an audit trail for decision review. The ability to exclude specific non-critical fields, such as comment fields from the double-key entry process can greatly increase efficiency. A single-key data entry mode should also be available to support EDC.

DZS Answer:
The double-key data entry process used in ClinPlus Data Management is a single database on-line verification method. All differences between 1st and 2nd key entry are logged and may be printed and reviewed. A single key mode is also available or individual fields can be designated as single-key only.

Q28. Can your software incorporate databases from other sources?

Reason for asking:
This can include lab data, data from a client or other third party. This functionality may also be used to support other technologies such as OCR or fax.

DZS Answer:
The Import feature of ClinPlus Data Management has many uses including importation of lab data, converting data from another data management system into ClinPlus, OCR, and fax or for importing data structures defined outside ClinPlus. This module will import data, create all tracking and enrollment records and generate a data entry screens as needed in a single step.

Q29. Is there any degradation in performance when multiple users access the system?

Reason for asking:
You should determine this impact for concurrent system access, protocol access and table access. Determine any available remedies such as purchasing memory or more powerful computers.

DZS Answer:
This largely depends on your overall network performance. If your network is over taxed, has bottlenecks or you notice a slowdown in other applications during heavy load periods then of course ClinPlus may also suffer. However, in a well-configured network we have seen little or no performance degradation regardless of the number of users.  However, batch processing of data may result in some performance degradation for users accessing the same data during that time.  

Q30. What is the relationship between database size and performance?

Reason for asking:
There should be no performance degradation regardless of database size.

DZS Answer:
ClinPlus Data Management relies heavily on SAS indexes to allow instant random retrieval of records for data entry or update regardless of database size.  Naturally, batch process time will lengthen as database size grows.  

Q31. How are SAS data sets generated?

Reason for asking:
Because the FDA requires that data be submitted as SAS version 5 transport files and analysis is almost always performed using SAS, you will most likely need SAS data sets at some point. If data is not initially stored as SAS data sets then you will need to determine how they will be created. If extraction/conversion programs need to be written, you need to know what skill sets are required. You should also consider validation issues related to the conversion process and the maintenance of two databases.

DZS Answer:
Data is stored as SAS data sets from the outset so there are no conversion programs or third party software needed. Furthermore, data is always available for analysis and report generation by SAS programmers and statisticians. ClinPlus Data Management also includes an export feature to allow copying and sub-setting of data and the creation of SAS transport files.

Q32. What user documentation is available?

Reason for asking:
Ask to see the User guide, training guide and on-line documentation. It should be complete, well organized and easy to understand.

DZS Answer: 
 All DZS software includes comprehensive, indexed and searchable online help.  A printable version is also provided on the installation media.  Training guides are also provided during training sessions.  DZS also maintains a User Forum accessible via our website that contains a wealth of additional information, tips, examples, etc. 

Q33. What does your software cost?

Reason for asking:
Keep in mind that the price of the software is but one line item in determining system cost. Other things to consider are: hardware costs, third party software licenses, implementation charges, training charges, additional support staff required (IT, DBAs, programmers, data management staff, etc.) and ongoing maintenance charges. Before deciding, find out how the software is priced (per seat, per site, average concurrent user, and blocks of users. You may also wish to explore available payment options.

DZS Answer:
DZS offers a one-time license fee, a leasing program or can design a payment program that will fit your unique requirements. The leasing program includes maintenance (tech support and all upgrades) while a separate maintenance agreement is required for the one-time license. You will also need SAS licenses (Base, AF and Share) for each user and it is recommended that you have at least one SAS programmer for internal support. You may contact a ClinPlus sales representative toll free at 1-866-CLINPLUS or email us at sales@clinplus.com to discuss your requirements and options.

Prepared by
DZS Software Solutions
ClinPlus® Clinical Trials Software