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Issues with rules

Dear all,
1. I create a rule for a new study. I check the target line several times but the system keeps giving me an error message (see below), can you help figurer this (attached is the XML metadata file)
2. If I have repeating events (occurrence 1, occurrence 2 etc) and I want the rule to fire only on the first occurrence what should I write in the target?
Thanks,
Shmulik
OpenClinica: An error has occurred
An error has occurred in the application. This can be for a number of reasons, not all of them might have to do with the actual Web application. If there are any messages above this text, please cut and paste them into an email to Akaza Research.
If there are no messages, you might try clicking on the links in the header, and see what happens. This might reinitialize your connection with the database. Or click here to take you back where you came from.
In any event, if you cant get back to a working page, please let us know. Please be sure to include
what you were doing,
when it happened,
and any other details (like error messages) that might be important.
Thanks,
The OpenClinica Development Team

Best regards,
Shmulik Adler
Clinical Trials Manager.
****************************************
A. Stein - Regulatory Affairs Consulting
Beit Hapaamon (Suite 102)
20 HaTaas Str. (P.O.B. 124)
Kfar Saba 44425 ISRAEL
Tel: +972-9-7670002
Fax: +972-9-7668534
E-mail: [email protected]
*****************************************
This message and any included attachments are from A. Stein - Regulatory Affairs Consulting and are intended only for the addressee(s). The information contained herein may include trade secrets or privileged or otherwise confidential information. Unauthorized review, forwarding, printing,copying, distributing, or using such information is strictly prohibited and may be unlawful. If you received this message in error, or have reason to believe you are not authorized to receive it, please promptly delete this message and notify the sender by e-mail.

Training and Demo Study_20100630214835.txt


Training and Demo Study

Training and Demo Study

Training and Demo Study




%




CM




HH:MM



























































































































































































































































































































































































































Date of Patient Enrollment






Date of informed consent:






Marital Status







Date Of Birth






Gender







If FEMALE, Please answer the following questions













If "YES" fill in the date of the pregnancy test






Race (check one or more)






If "Other", please specify






Years of Education







I HEREBY CONFIRM THAT THE PATIENT WAS DIAGNOSED AS CURRENTLY HAVING AN EPISODE OF MAJOR DEPRESSION DISORDER (MDD) USING THE STRUCTURED CLINICAL INTERVIEW FOR DSM DISORDERS (SCID)






Did PI signed of the first page of the CRF?







Date of Signature






1.Outpatients







2.Men and women 22-68 years of age.







3.Primary DSM-IV diagnosis of Major Depression, single or recurrent episode confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV), with the additional requirements of a current episode ≥4 weeks and CGI-S ≥4.







4.Current depressive episode is less than 5 years duration (the definition of an episode is demarcated by a period of ≥2 months in which the patient did not meet full criteria for the DSM-IV definition of major depressive episode).







5.Total HDRS-21 ≥20 and Item 1 score ≥2 at the screening visit.







6.The patient didn't respond to at least 1 antidepressant treatment, i.e., a minimum of 1 and a maximum of 4 antidepressant drug trials of adequate dose and duration in the current episode, defined as a minimum level of 3 on the ATHF. Current episode for ATHF level 3 patients should be > 12 weeks;







7.Patients who have not completed antidepressant trials of adequate dose and duration (defined as a level of 1-2 on the ATHF) due to intolerance to therapy if they have demonstrated intolerance to 2 or more anti-depressant medications in the current episode







8. Capable and willing to provide informed consent.







9.Able to adhere to the treatment schedule, and withdrawal of ongoing pharmacotherapy.







10.If currently taking antidepressant pharmacotherapy, the patient must be clinically appropriate to discontinue treatment with those agents. “Clinically appropriate” is defined as removing patients from antidepressant medications without significantly increasing the risk of suicide or aggravating HDRS score by 30% or more.







11. Able to tolerate psychotropic medication washout and no psychotropics during the H-coil deep brain rTMS other than benzodiazepine at equivalent daily dose of up to 3 mg lorazepam.







12. Satisfactory safety screening questionnaire for TMS







13. Patients not suffering from hypo/hyper-thyroidism based on pre-study TSH level or medically stabilized.







Copy any comments on the inclusion criteria to the following textarea






1.Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption).







2.Subjects currently diagnosed (unless otherwise stated) by the Investigator with the following conditions:

























3. Individuals with a significant neurological disorder or insult including, but not limited to:





































4. Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes or familial or personal history of epilepsy.







5. Individuals with hearing loss.







6. A positive and unmitigated response to any question on the Transcranial Magnetic Stimulation Adult Safety Screen questionnaire.







7. ECT treatment within 3 months prior to the screening visit.







8. Failure to respond to ECT treatment (i.e., consistent with ATHF level 2 or higher) in this or any previous episode.







9. History of treatment with rTMS therapy for any disorder.







10. History of treatment with Vagus Nerve Stimulation (VNS).







11. History of treatment with Deep Brain Stimulation (DBS)







12. Use of any investigational drug within 4 weeks of the randomization visit.







13. Use of Fluoxetine within 6 weeks of the randomization visit.







14. Use of a MAO-I within 2 weeks of the randomization visit.







15. Use of any medication(s) listed on the Excluded Medication List within 1 week of the randomization visit







16. Present suicidal risk as assessed by the investigator or significant suicide risk based on HDRS-21 item 3 score of 3 or 4 or significant suicide risk as assessed using the Scale for Suicide Ideation - Worst or a history of attempted suicide in the last 3 years.







17. Any self-inflicted harm in the past 3 months not in the context of suicidal ideation.







18. Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.







19. Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed







20. Implanted neurostimulators







21. History of abnormal MRI







22. Known or suspected pregnancy.







23. If participating in psychotherapy treatment, the treatment in the last 3 months prior to entry into the study has been unstable, and is likely to change (e.g., frequency of therapeutic sessions, or therapeutic focus) over the duration of the rTMS trial.







24. Clinically significant laboratory abnormality, in the opinion of the Investigator based on CBC and biochemistry.





Comments

  • Hi Shmulik,
    Regarding question #1 - can you send me the logs of your Tomcat server off-list?
    Regarding question #2 - As it says in the rule documentation on the wiki, you can declare a rule like this:
    SED_OID[ALL].CRF_OID.GROUP_OID.ITEM_OID
    which will cover all the occurrences of that OID. Alternatively, you can declare it like this:
    SED_OID[1].CRF_OID.GROUP_OID.ITEM_OID
    and that will only fire on the first occurrence. Does that make sense?
    Best, Tom
    Tom Hickerson - [email protected]
    Senior Developer
    Akaza Research, LLC
    -----Original Message-----
    Sent: Thu 7/1/2010 0:50
    To: [email protected]
    Subject: [Users] Issues with rules

    Dear all,
    1. I create a rule for a new study. I check the target line several times
    but the system keeps giving me an error message (see below), can you help
    figurer this (attached is the XML metadata file)
    2. If I have repeating events (occurrence 1, occurrence 2 etc) and I want
    the rule to fire only on the first occurrence what should I write in the
    target?
    Thanks,
    Shmulik
    OpenClinica: An error has occurred
    An error has occurred in the application. This can be for a number of
    reasons, not all of them might have to do with the actual Web application.
    If there are any messages above this text, please cut and paste them into an
    email to Akaza Research .
    If there are no messages, you might try clicking on the links in the header,
    and see what happens. This might reinitialize your connection with the
    database. Or click here
    to take you back
    where you came from.
    In any event, if you cant get back to a working page, please let us know.
    Please be sure to include
    * what you were doing,
    * when it happened,
    * and any other details (like error messages) that might be important.
    Thanks,
    The OpenClinica Development Team

    Best regards,
    Shmulik Adler
    Clinical Trials Manager.
    ****************************************
    A. Stein - Regulatory Affairs Consulting
    Beit Hapaamon (Suite 102)
    20 HaTaas Str. (P.O.B. 124)
    Kfar Saba 44425 ISRAEL
    Tel: +972-9-7670002
    Fax: +972-9-7668534
    E-mail: [email protected]
    *****************************************
    This message and any included attachments are from A. Stein - Regulatory
    Affairs Consulting and are intended only for the addressee(s). The
    information contained herein may include trade secrets or privileged or
    otherwise confidential information. Unauthorized review, forwarding,
    printing,copying, distributing, or using such information is strictly
    prohibited and may be unlawful. If you received this message in error, or
    have reason to believe you are not authorized to receive it, please promptly
    delete this message and notify the sender by e-mail.

    Attachments:
    winmail.dat 4.0 KB
  • Hi,

    I am trying to upload a rule for a new study but every time I get the message ‘An error has occurred’. I’ve checked several times that the all the OIDs are correct, changed the rule name and that the rule works under the ‘Test Rules’. I get the same error message when trying to upload different versions of CRFs.

    I was using version 3.0.1 on Linux but have since upgraded to 3.0.3 and I still receive the same error.

    Thanks,

    Matt
This discussion has been closed.