Frequently Asked Questions

Click on a question to view the answer:

General

Data entry

MedDRA Coding

Reported Address (CIOMS / MedWatch)

Reporting

Case management


Answers

What do I do if I forget my password?

To reset your password, navigate to the PV247 login screen at www.pv247.com/pv247/login and follow these simple steps:

  1. Enter the email address that is registered with PV247 in the 'Email address' field.
  2. Click the 'Forgotten your password?' link.
  3. Confirm that you wish to reset your password
  4. A message will appear, explaining that your new password will be sent to you by email.
  5. When your new password arrives enter it into the login screen as normal.
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What do I do if I have forgotten my memorable word?

If you have forgotten the memorable word that you use to log-in to PV-Works, please contact support by email at support@assured.co.uk and we will reset it for you. Then you will be able to create a new one.

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I have finished testing, what do I do to start production work?

Please send an email to our support team at support@assured.co.uk so that we can update your account. This will prevent it becoming disabled once it is 30 days old.

If you are a Premium package user, simply log-on to your separate production system using your production username.

If you are an Essentials user you should delete the test cases that you do not wish to keep and then reset the case numbers so that they can be re-used. To do this:

  1. Delete case by selecting the case, selecting “Delete case” from the “File” menu and follow the instructions.
  2. Repeat this for every test case to be deleted.
  3. Reset case numbers by selecting the “Reset Test Case Numbers” function from the “Configuration” button.
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Are there any additional fees to pay?

The pricing page shows all prices, there is no additional fee to be paid upfront.

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Are the prices 'time-limited'?

The prices displayed on this website are time-limited, these prices will remain in place until 30th June 2013. We intend to review prices once per year. However, for customers who wish to pay in euros or US Dollars, we reserve the right to adjust these prices if there are major currency exchange variations.

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How do I add contacts to my case?

To find out how to add contacts to a case, or correct errors with existing contacts please visit our Managing Contacts in PV-Works guide.

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When the same LLT term maps to 2 or more SOCs, how do you know which is the primary SOC?

The Primary SOC is always the first one in the list shown when coding. It is also marked with a little black triangle on the left hand side.

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How is the MedDRA dictionary updated?

New versions of MedDRA are issued on 1 March and 1 September each year and need to be in use on the first Monday in the month of May and November respectively. All updates will be performed on your behalf by the Assured support team.

For all customers the update will take place over the week-end before the implementation date.

Note: all customers need to maintain a subscription for the MedDRA dictionary at all times.

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As a CRO how do we ensure that it is our customer’s address that appears on a CIOMS or MedWatch report?

PV-Works can print several different types of name and address as the manufacturer:

  • Safety Reporting Group (ie the CRO)
  • Market Authorisation Holder
  • Manufacturer
  • Sponsor

Owing to the fixed configuration for Essentials package users, manufacturer is the most limiting category of these as only one address can be associated per country. However, an Essentials system allows you to define up to 7 Market Authorisation Holders and an unlimited number of Clinical Trial Sponsors. Premium package users have no restrictions.

Placing a specific address on the screen is a two or three step process:

  1. Enter the name and address using the Configuration | Contacts and Locations screen.
    Select the address type in the “Location type” box:
  2. For Clinical Trials, define the trial itself (including its sponsor) using the Configuration | Clinical Trials screen
  3. Select the appropriate address type when running the report.
    This is selected in the report set up screen for the CIOMS (or MedWatch) report.
    Go to the “Display” tab...

    ...and select the address type from the drop down list 'display as manufacturer as sponsor' for CIOMS ('Company reporter' for Medwatch).

    PV-Works will use the data in the case to determine the correct Manufacturer, Market Authorisation Holder or Sponsor and will print the appropriate address.
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Why doesn’t my case appear on my PSUR line listing?

When a PSUR is run PV-Works applied a number of conditions to determine the cases that will be listed. If you have a case that is not included but you believe it should then check the following conditions in the case.

When looking at a case that has been report approved remember that the highest version of the case is used. It is possible that the critical data item in the list below has been fixed in the master version but that the case has not been re-approved since the edit…. And the version is wrong.

Detailed Criteria:

For a case to be selected in a PSUR run it must satisfy ALL of the following rules. Failure to meet one of these conditions will result in the case being excluded:

  1. Case must be received between the two dates specified on the selection screen. The ‘date first received’ and the ‘date of latest follow up’ are both used for this purpose (ie include reports received initially or as follow ups during the target period). The two end dates are included in the filter.
  2. The case must be confirmed (on Case Identification screen)
  3. The case must include a company product that is one of the selected products for the run. In the current version the product will be included regardless of its role in the case.
  4. Case must be received:
    Source Determined from
    spontaneously case identification screen – case type
    from a clinical trial case identification screen – case type
    from a post-marketing study case identification screen – case type
    from the literature case identification screen – source
    directly from a regulatory authority case identification screen – source
  5. Case must be assessed for seriousness:
    Seriousness is determined using the following hierarchy, searching the case at each level until a non-null value is found. Only if all levels are exhausted without a seriousness value being found, will a selected case be determined to have no assessment (and is therefore excluded from the run):
    1. Seriousness of the most important event
    2. Case level assessment
  6. Case must be assessed for expectedness
    Expectedness is determined using the following hierarchy, searching the case at each level until a non-null value is found. Only if all levels are exhausted without an expectedness value being found, will a selected case be determined to have no assessment (and is therefore excluded from the run):
    1. label specified by user on the PSUR set up screen
    2. CORE label (company [global] label)
    3. INV label (investigator's)
    4. local label in country of occurrence
    5. case level assessment
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How do I set up a sending authority for XML Case Exports?

In order to populate your XML Export with the correct sender details, it is important that you configure at least one Receiving Authority. This can be done from the Contacts and Locations option on the Configuration menu.

Click Add to create a new entry and set the Location type to 'Receiving Authority'. Make sure you include full location and contact details, including an appropriate XML Sender:

Multiple Sending authorities can also be set up by creating additional Receiving Authorities on the Contacts and Locations screen.

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How do I restore a case that has been deleted?

If you have deleted a case (using the File | Delete case function) and need to have it restored, please contact support by email at support@assured.co.uk and we will do this for you.

(Note that in a future release we will introduce a function for you to do this yourself).

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How do I unlock a case that the system says is open already by a different user or by me?

This situation can occur if the network connection breaks and the server is unable to restore your system to its previous state just before the failure. If you have a locked case, please contact support by email at support@assured.co.uk and we will unlock the case for you.

(Note that in a future release we will introduce a function for you to do this yourself).

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Click on a question to view the answer:

General

Data entry

PSUR

Case management


Answers

What do I do if I forget my password?

To reset your password, navigate to the PV247 login screen at www.pv247.com/pv247/login and follow these simple steps:

  1. Enter the email address that is registered with PV247 in the 'Email address' field.
  2. Click the 'Forgotten your password?' link.
  3. Confirm that you wish to reset your password
  4. A message will appear, explaining that your new password will be sent to you by email.
  5. When your new password arrives enter it into the login screen as normal.
Back to Top

What do I do if I have forgotten my memorable word?

If you have forgotten the memorable word that you use to log-in to PV-Works, please contact support by email at support@assured.co.uk and we will reset it for you. Then you will be able to create a new one.

Back to Top

I have finished testing, what do I do to start production work?

Please send an email to our support team at support@assured.co.uk so that we can update your account. This will prevent it becoming disabled once it is 30 days old.

If you are a Premium package user, simply log-on to your separate production system using your production username.

If you are an Essentials user you should delete the test cases that you do not wish to keep and then reset the case numbers so that they can be re-used. To do this:

  1. Delete case by selecting the case, selecting “Delete case” from the “File” menu and follow the instructions.
  2. Repeat this for every test case to be deleted.
  3. Reset case numbers by selecting the “Reset Test Case Numbers” function from the “Configuration” button.
Back to Top

Are there any additional fees to pay?

The pricing page shows all prices, there is no additional fee to be paid upfront.

Back to Top

Are the prices 'time-limited'?

The prices displayed on this website are time-limited, these prices will remain in place until 30th June 2013. We intend to review prices once per year. However, for customers who wish to pay in euros or US Dollars, we reserve the right to adjust these prices if there are major currency exchange variations.

Back to Top

How do I add contacts to my case?

To find out how to add contacts to a case, or correct errors with existing contacts please visit our Managing Contacts in PV-Works guide.

Back to Top

Why doesn’t my case appear on my PSUR line listing?

When a PSUR is run PV-Works applied a number of conditions to determine the cases that will be listed. If you have a case that is not included but you believe it should then check the following conditions in the case.

When looking at a case that has been report approved remember that the highest version of the case is used. It is possible that the critical data item in the list below has been fixed in the master version but that the case has not been re-approved since the edit…. And the version is wrong.

Detailed Criteria:

For a case to be selected in a PSUR run it must satisfy ALL of the following rules. Failure to meet one of these conditions will result in the case being excluded:

  1. Case must be received between the two dates specified on the selection screen. The ‘date first received’ and the ‘date of latest follow up’ are both used for this purpose (ie include reports received initially or as follow ups during the target period). The two end dates are included in the filter.
  2. The case must be confirmed (on Case Identification screen)
  3. The case must include a company product that is one of the selected products for the run. In the current version the product will be included regardless of its role in the case.
  4. Case must be received:
    Source Determined from
    spontaneously case identification screen – case type
    from a clinical trial case identification screen – case type
    from a post-marketing study case identification screen – case type
    from the literature case identification screen – source
    directly from a regulatory authority case identification screen – source
  5. Case must be assessed for seriousness:
    Seriousness is determined using the following hierarchy, searching the case at each level until a non-null value is found. Only if all levels are exhausted without a seriousness value being found, will a selected case be determined to have no assessment (and is therefore excluded from the run):
    1. Seriousness of the most important event
    2. Case level assessment
  6. Case must be assessed for expectedness
    Expectedness is determined using the following hierarchy, searching the case at each level until a non-null value is found. Only if all levels are exhausted without an expectedness value being found, will a selected case be determined to have no assessment (and is therefore excluded from the run):
    1. label specified by user on the PSUR set up screen
    2. CORE label (company [global] label)
    3. INV label (investigator's)
    4. local label in country of occurrence
    5. case level assessment
Back to Top

How do I restore a case that has been deleted?

If you have deleted a case (using the File | Delete case function) and need to have it restored, please contact support by email at support@assured.co.uk and we will do this for you.

(Note that in a future release we will introduce a function for you to do this yourself).

Back to Top

How do I unlock a case that the system says is open already by a different user or by me?

This situation can occur if the network connection breaks and the server is unable to restore your system to its previous state just before the failure. If you have a locked case, please contact support by email at support@assured.co.uk and we will unlock the case for you.

(Note that in a future release we will introduce a function for you to do this yourself).

Back to Top