CDR Tickets

BZDATETIME::2010-04-12 11:37:03
BZCOMMENTOR::Bob Kline
BZCOMMENT::1

Before I did anything with these, I just wanted to make sure that you're aware that two of the four have a disposition of 'imported' (and for those two the cdr_id column hold the CDR ID for the CT.gov protocol document instead of the InScopeProtocol document), and that deleting the rows from the table is what you want me to do for all four protocols.

BZDATETIME::2010-04-12 15:11:57
BZCOMMENTOR::William Osei-Poku
BZCOMMENT::2

(In reply to comment #1)
> Before I did anything with these, I just wanted to make sure that you're aware
> that two of the four have a disposition of 'imported' (and for those two the
> cdr_id column hold the CDR ID for the CT.gov protocol document instead of the
> InScopeProtocol document), and that deleting the rows from the table is what
> you want me to do for all four protocols.

What will happen if the CDR IDs for the two documents are deleted? We have marked the corresponding InScope protocols to be transferred. Will deleting the CDR IDs of the two you mentioned above prevent the documents from being transformed?

BZDATETIME::2010-04-13 08:03:47
BZCOMMENTOR::Bob Kline
BZCOMMENT::3

(In reply to comment #2)

> What will happen if the CDR IDs for the two documents are deleted? We have
> marked the corresponding InScope protocols to be transferred. Will deleting the
> CDR IDs of the two you mentioned above prevent the documents from being
> transformed?

Do you mean deleting the CDR IDs (and if so, deleting them from where? the columns in the ctgov_import table?) or do you mean deleting the documents themselves?

BZDATETIME::2010-04-13 08:56:29
BZCOMMENTOR::Lakshmi Grama
BZCOMMENT::4

(In reply to comment #1)
> Before I did anything with these, I just wanted to make sure that you're aware
> that two of the four have a disposition of 'imported' (and for those two the
> cdr_id column hold the CDR ID for the CT.gov protocol document instead of the
> InScopeProtocol document), and that deleting the rows from the table is what
> you want me to do for all four protocols.

Can you tell me which two are marked as "imported"

BZDATETIME::2010-04-13 09:36:54
BZCOMMENTOR::Bob Kline
BZCOMMENT::5

NLM (NCT) ID Disposition CDR ID
NCT00194792 imported 452124
NCT00228358 duplicate 551901
NCT00448201 imported 542709
NCT00448357 duplicate 550145

BZDATETIME::2010-04-13 09:49:24
BZCOMMENTOR::William Osei-Poku
BZCOMMENT::6

(In reply to comment #3)
> (In reply to comment #2)
> > What will happen if the CDR IDs for the two documents are deleted? We have
> > marked the corresponding InScope protocols to be transferred. Will deleting the
> > CDR IDs of the two you mentioned above prevent the documents from being
> > transformed?
> Do you mean deleting the CDR IDs (and if so, deleting them from where? the
> columns in the ctgov_import table?) or do you mean deleting the documents
> themselves?

I meant - to delete the rows in the ctgov_import table for these trials. Sorry about the confusion. I am trying to accomplish the same things you did in OCECDR-3056 and OCECDR-3085.

BZDATETIME::2010-04-14 12:17:32
BZCOMMENTOR::Lakshmi Grama
BZCOMMENT::7

(In reply to comment #5)
> NLM (NCT) ID Disposition CDR ID
> NCT00194792 imported 452124
> NCT00228358 duplicate 551901
> NCT00448201 imported 542709
> NCT00448357 duplicate 550145

I see that the two trials are actually CDR trials that have been imported from CTGOV post-transition. I guess I don't understand teh rationale for removing them from the CTGOV Import table. Are we taking back ownership - what is going on? William, when you ask for records to be deleted, please make sure there is an explanation of why. ALso, I am confused about why the Inscope Record says Block from CTGOV?

BZDATETIME::2010-04-14 13:12:30
BZCOMMENTOR::William Osei-Poku
BZCOMMENT::8

> I see that the two trials are actually CDR trials that have been imported from
> CTGOV post-transition. I guess I don't understand the rationale for removing
> them from the CTGOV Import table. Are we taking back ownership - what is going
> on?
For all of these trials, CIAT -Lockheed added the transfer blocks but they never got transformed into CTGov protocols. Typically, if this happens and they are on the Adhoc report - Transfer Trials Not Received from NLM, we do a force download of the trials and get the transformed documents.
The difficulties with these transfer trials start when they have corresponding CTGov duplicate trials with the same NCT ID. These are typically the ones that we first imported the CTGov trial and later got the InScope trial and the submitters agreed to update in both databases so we block the CTGov trials and publish the InScope trials and Block them from going to CTGov.
In certain situations we use the Mark/Remove Protocols as Duplicates interface to remove the duplicates from some of them before they are transformed. But we do this typically for trials that we do not have a corresponding CTGov duplicate.
The ones that we are not sure of why they were not transformed and the ones that a force download does not transform, we send to Bob.
>William, when you ask for records to be deleted, please make sure there is
> an explanation of why.
Thanks, Lakshmi. Will do.
>ALso, I am confused about why the Inscope Record says
> Block from CTGOV?
The InScope documents say Blocked from CTGov because it is part of the transfer process to add the element. When we don’t add the element, the trials get registered again as new trials in CTGov.

BZDATETIME::2010-04-15 13:58:43
BZCOMMENTOR::Lakshmi Grama
BZCOMMENT::9

>>For all of these trials, CIAT -Lockheed added the transfer blocks but they
>>never got transformed into CTGov protocols

Actually if you look at those two trials in the CDR, they are CTGOV trials that were originally Inscope trials. The protocol id is the CDRID. So what am I missing?

BZDATETIME::2010-04-15 15:26:17
BZCOMMENTOR::William Osei-Poku
BZCOMMENT::10

(In reply to comment #9)
> >>For all of these trials, CIAT -Lockheed added the transfer blocks but they
> >>never got transformed into CTGov protocols
>
> Actually if you look at those two trials in the CDR, they are CTGOV trials that
> were originally Inscope trials. The protocol id is the CDRID. So what am I
> missing?

I looked at the history of changes on clinicaltrials.gov and compared with the corresponding CTGov document in the CDR and noticed that sometime in the past, CTGov had added the CDR IDs as org_study_id to these trials. This may have happened at the point when we informed them that we were taking ownership of the trials. (In both cases, the history indicates that we were not the original registrant of the studies.) This is likely what is preventing the conversion of the documents.

For 542709 the history (on clinicaltrials.gov) indicates that the org_study_id was changed to the CDR ID from LCC 0306 on 2007-05-23. We got this change in version 7 of the document in the CDR which happened on 2007-05-26.

http://www.clinicaltrials.gov/ct2/show/NCT00448201?term=NCT00448201&rank=1

For 452124, the history of changes on clinicaltrials.gov indicates that the switch from the original org_study_id to the CDR ID occurred in 2007-09-13. And it was changed from 03-8482-B. However, we did not receive this change until Version 34 of our CDR document on 2010-02-25, a day after we put the transfer block in the InScope document.

http://www.clinicaltrials.gov/ct2/show/NCT00194792?term=NCT00194792&rank=1

BZDATETIME::2010-04-15 16:05:47
BZCOMMENTOR::Bob Kline
BZCOMMENT::11

I deleted the two rows for NCT00448357 and NCT00228358.

BZDATETIME::2010-04-16 11:50:21
BZCOMMENTOR::William Osei-Poku
BZCOMMENT::12

(In reply to comment #11)
> I deleted the two rows for NCT00448357 and NCT00228358.

Verified . Thank you!

Yesterday on the phone call with Lakshmi and Bob, we decided that CIAT will manually extract indexing and admin info elements to the existing ctgov documents and ensure that the InScope document is blocked from publication. CIAT will also check to see if we are receiving updates from CTGov for these trials.
We are extracting the elements for the other two trials that were not deleted from the ctgov_import table.

I am closing this issue.

BZDATETIME::2010-04-16 11:50:53
BZCOMMENTOR::William Osei-Poku
BZCOMMENT::13

Issue now closed.