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Question & Answers

General


How much does CtDatabank cost?

CtDatabank has an annual subscription fee, per Trust, that is based upon the number of active trials stored in the database - not how many trials you are running in the hospital. The trial numbers are banded and we will ask you what the levels will be for the forthcoming year and charge accordingly.
 
The trial bands are:

1 - 10;  11- 25;  26 - 50;  51 - 100;  101 -150;  151 - 250;  >250. 
Please contact us for actual prices.

This means that you can start off in the lowest band and increase trial numbers as required.  If you wish to deploy across a region we would need to look at the number of trials in each Trust and deal with each one independently.

 

How much does support cost?

Application support is included in the subscription fees. We do reserve the right to agree and charge fees for extras e.g. data import.

 

Will there be new releases of the software made available?

Yes, and they will be included as part of your annual subscription. The software will naturally evolve to reflect requests from users and perhaps changes in regulation. Because CtDatabank is web-based, the changes will be made at CoAcS and will not require any IT assistance or installation in your Trust.

 

What training is offered?

We recommend that somebody (perhaps the system administrator) is trained by CoAcS. Ideally all users should be trained but we appreciate that this is not always practical. It also depends upon your requirements and how complex your trials might be. CtDatabank is intuitive to run so getting started should be easy enough. We do supply a user and admin manual and the website will provide detail too. On-site training from CoAcS costs £620 per day.

 

What software do I need on my computer to run CtDatabank?

You only need a standard web browser to run CtDatabank and it can be operated outside of the Trust environment. We recommend Chrome and IE (below v11).

CtDatabank will run successfully on a tablet device too.


How do I access CtDatabank?

Over the Internet via a web browser requiring a unique username and password. This will define your individual access rights.

 

Does CtDatabank link to any other systems?

Not currently as there are so many available systems. However, an export feature is planned and possibly a patient import facility. Labeling can now be done with CtDatabank in v2.

 

Will CtDatabank replace our paper systems and spreadsheets?

Probably not entirely as some people like to print things regardless. CtDatabank, however, does include a facility to print trial information in a concise ‘printer-friendly’ format. CtDatabank will dramatically reduce the amount of paper and files used in your department. You will be able to make large savings in storage space and retrieval time.

 

Can CtDatabank handle commercial and non-commercial trials?

Yes. The stock area can handle external stocks that are bought in and invoices can be created. We know that some pharma companies like hospital pharmacy departments to use their own systems for trial data - but that can make things quite hard for staff when dealing with multiple sponsors. CtDatabank can provide a standardised solution.

 

Functionality


Can attachments be added in records?

Yes – important documents, like the protocol description, can be stored and given names. However, CtDatabank is not a document management system and we suggest that document creation and versioning etc. is done elsewhere.

 

Is there a rich text editor?

Yes. This will help you to add tables and formatting to text - like your trial description and labels.

 

Do I get reminders about pending events?

Whenever you log in you will be alerted if there are any outstanding tasks to be performed e.g. an overdue invoice or verification of GCP changes.

 

Is it possible to anonymise patient data?

Yes. This setting can be set by your administrator and will remove the patient’s name and other details. An internal patient number will be used for identification purposes.

 

How is stock handled?

It’s not possible to dispense without setting an initial stock amount but thereafter drugs can be dispensed as required. Stock reconciliation can be made using the stock report printout. A zero stock warning can be configured.
 

Can sponsors / monitors see the dispensing records?

Yes. Trial monitors can be explicitly assigned to see individual anonymised trial dispensing records. They can add comments but not edit anything else. This can be a temporary or permanent access.

 

What reports are available?

Flexible reports are available at a summary and detail level. All the trials for a Trust can be listed (showing dates and Status) and financial reports will summarise cost and expenditure. Within each trial, it’s possible to track stock control and movements. Other views will list patients and their dispensing history.

 

Finance


How are invoices set up?

CtDatabank uses terms in the NHS cost template. System administrators are required to set up the staffing and drug costs at the trial onset and these will be used throughout the trial duration.

 

Who controls the costs?

The Finance owner determines the costs to be used in the invoicing. Not all users will be able to see this data, though.

 

When are invoices produced and who produces them?

Invoices can be produced on demand and the frequency of them is set accordingly. You will probably want to work in agreement with your finance dept though. Finance people can either be sent the data in hard copy format or be set up as users and see the data for themselves.

 

Security


Can I be sure that my data is safe?

Yes. We can supply a statement on security. The database itself is stored in a secure off-site location with physical and electronic safeguards. Redundancy and regular backups ensure nothing can be lost. Data transfer is encrypted and supported via SSL using Verisign certification.

 

Will we be able to see trial data for other Trusts?

No! Each participating Trust will only have access to their own clinical trial and admin data.

 

Is there an audit trail? Can I see old data values?

Yes. All of the data entered into CtDatabank is stored in the database. In v2, there is now a complete user friendly audit trail that can reset the dispensing records back to any point in time.

 

What checking procedures are in CtDatabank?

Some procedures are optional - for example, checking a dispensing record. Many procedures must follow strict guidelines e.g. changing trial status. Some procedures may require a username and password to be entered and this will become embedded in the audit trail.

 

What happens regarding the long-term storage of trial information?

CoAcS will store the information and make it accessible for as long as required. It is ultimately protected by an Escrow contract.