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The Responsible Party can be either a sponsor or a principal investigator (PI). The term "responsible party" is either of the following:
If the Responsible Party is the Principal Investigator, this section expands to display the investigator's title and organization affiliation. The investigator's name is generated from the name you selected as Principal Investigator in the Lead Organization/Principal Investigator section. If the Responsible Party is the Sponsor-Investigator, this section expands to display the investigator's name and title. The investigator's name is generated from the name you selected as Principal Investigator in the Lead Organization/Principal Investigator section. However, you can change the investigator's name in this case. How to Complete the Sponsor/Responsible Party Section In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field. Instructions for recording Sponsors/Responsible Parties
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Abstracting Central Contacts
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How to Complete the Central Contacts Section In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. All central contact information is optional.
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You can associate, or link, collaborating organizations with the trial you are abstracting. Collaborator information is included in the Protocol document or in the uploaded Participating Sites document. It is optional for Abbreviated trials. To delete a previously linked collaborator, see Deleting Collaborators From a Trial.
Linking Collaborators to a TrialHow to Link Collaborators to a Trial
Deleting Collaborators From a Trial
If a collaborator currently linked to the trial you are abstracting is incorrect, you can delete it from the trial. How to Delete a Collaborator From a Trial
Editing Collaborator RolesIf the role of a collaborator currently linked to the trial you are abstracting is incorrect, you can change the functional role. How to Edit Collaborator Roles
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The information you are required to provide depends on the Board approval status and other indicators, as noted in the instructions that follow. Human subject safety information is optional for Abbreviated trials.
Some fields in this section are optional, and some may be required only when you have selected certain attributes in preceding fields. For example, if the Board Approval Status is "Submitted, exempt", the Board Name, Board Affiliation, and Board Contact fields are mandatory, but the Board Approval Number is optional. The following table provides a matrix of field requirement dependencies. Matrix of field requirements
How to Abstract Human Subject Safety Information
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NCI-Specific Information applies to Complete and Abbreviated trials. For Abbreviated trials, indicate whether or not the trial is Industrial.
Included in this section is the option, for certain trials, to include them in, or exclude them from, the batch of trials that CTRP sends to ClinicalTrials.gov via FTP nightly.
How to Abstract NCI-Specific Information
Industrial? Values
For Abbreviated trials, indicate whether the trial is an Industrial trial or other category, according to the Data Table 4 Category values below. The Consortia Trial Indicator is internal to the CTRP system.
Conditions for Sending Trial Information to ClinicalTrials.gov
Following are the inclusion criteria the system uses to determine the set of CTRP trials to send to ClinicalTrials.gov:
The System will exclude from sending all trials that meet one or more of the following criteria:
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Trials are conducted in participating sites. You must provide information about the site itself (organization), the investigator(s), and primary contacts (if a central contact is not provided). Optionally, you can include contact information for a person’s title (functional role) rather than a person’s name. When you add a participating site to a trial, link (associate) an organization, site, investigator(s), and primary site contact information to it.
Information about participating sites can be included in the protocol document or in the Participating Sites document.
How to Abstract Participating Site Information
Abstracting Participating Site Information for Complete Trials
How to Abstract Participating Site Information for Complete Trials
Site Recruitment Status Definitions
Adding Generic Participating Site ContactsHow to Add a Generic Participating Site Contact
Abstracting Participating Site Information for Abbreviated Trials
How to Abstract Participating Site Information for Abbreviated Trials
Editing and Deleting Participating Site RecordsIf a participating site record currently associated with the trial you are abstracting is incorrect, you can edit or delete the site. How to Edit or Delete a Participating Site From a Trial
Editing and Deleting Participating Site Recruitment Status RecordsThe system validates participating site recruitment status transitions according to the criteria described in Abstracting Trial Status Histories.
How to Edit and Delete Participating Site Recruitment Status Records
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