HRECTrack has the ability to import certain electronic (i.e. non-paper) documents.

Broadly, these are :-

• HREA Application (zip file),

•HRECTrack PDF E-Docs.

 

Management of HREA / PDF E-Doc documents, including uploading and issue identification are all handled via the 'Dashboard - EDM' page.

 

HRECTrack PDF E-Docs include :-

• (Researcher) Application Form,

• Project Application Form,

• Progress Reports,

• Amendments,

• Severe Adverse Events, and

• Documents (default).

 

These PDF E-Docs documents can be filled in on any device (PC, Mac, Apple or Android), at the researchers leisure, and once completed, can be emailed to the HREC, or uploaded by the Researcher into HRECTrack directly (provided the HREC has given access to the Researcher).

n.b. We STRONGLY recommend Adobe Reader as the editor of choice on EVERY platform (yep, underlined, in bold, that strongly) !

 

Once uploaded, the HREC administrator can vet the document (via  on their dashboard), review any issues, and liaise with the researcher if required.

Once satisfied that the 'form' has been successfully completed, they can select the import () option to get HRECTrack to process the document, which, depending on the document type, will :-

• Researcher Application Form :-

•Create a new researcher
n.b. will NOT duplicate/overwrite existing researcher, see below.

•Add the email contact for the researcher,

•Optionally add other contact options,

•Optionally add other address options.

•Open the new researcher record for additional updates by the administrator.

•Project Application Form :-

•Create a new project in the system,

•Associate the PDF document to the project as an application,

•Optionally associate drug(s) details,

•Optionally associate device(s) details,

•Optionally associate previous project link(s),

•Optionally create and/or associate a sponsor.
n.b. Sponsors are uniquely identified by their ABN, and an existing Sponsor will not be duplicated or overwritten.

•Optionally create and/or associate researcher(s) according to their pre-defined roles (e.g. Principle, Chief, etc).
n.b. will NOT duplicate/overwrite existing researcher, see below.

•Open the new project record for additional updates by the administrator.

• Progress Report,

•Create a new Progress Report against a project,

•Associate the PDF document to the project and the Progress Report.

•Open the new progress report record for additional updates by the administrator.

• Amendments,

•Create a new Amendment against a project,

•Associate the PDF document to the project and the Amendment.

•Open the new Amendment record for additional updates by the administrator.

• Severe Adverse Events,

•Create a new Severe Adverse Event against a project,

•Associate the PDF document to the project and Severe Adverse Event.

•Open the new Severe Adverse Event record for additional updates by the administrator.

• Documents,

•Create a new Document against a project,

•Optionally sets the document type (details below) otherwise 'Unknown' type,

•Open the new Document record for additional updates by the administrator.

 

 

Technical Bits N Pieces...

 

E-Docs (electronic documents) can be created and controlled by the HREC.

The following section outlines what is required in an Electronic Document for HRECTrack to process it.

Creation of the document (form) can be performed in tools like Adobe Acrobat DC.

Alternatively, we use and recommend Jonathan Pike to create your forms.

 

To create an editable PDF document, HRECTrack expects the document to conform to some basic conventions, namely :-

•meta-data tags (document properties) set for the document :-

•hrecCode - the 'internal' code for the HREC,

•hrecDocType - denoting the type of document, namely :-

•"Project",

•"Amendment",

•"ProgressReport",

•"SAE",

•"Researcher",

•"HMReview", or

•"Document".

•hrecProjectId - is the project identifier for a specific project.
Can be derived from the "ProjectCode" document field (see below).
This tag is only required for :-

•"Amendment",

•"ProgressReport", or

•"SAE".

•hrecDocTypes, and if absent,

•hrecDocTypeId - only applies to hrecDocType = "Document". If present, this is the TypeId (see below) of the document type being imported. When absent, it is defaulted to the 'Unknown' document type; and can be changed by the admin.

•editable document fields defined for the relevant type as per the details below.

•a help link to the E-Docs Help page of this guide can also be included, see next section.

 

Once created, E-Docs can appear under the  'Reports' icon in the project listing. If selected, the E-Doc has the following information 'stamped' into it before export/download to the user :-

•hrecProjectId - meta-data field stamped for import,

•ProjectCode - display field in document,

•Title/ProjectTitle - display field in document,

•ProjectPI - principal investigator display field in document,

•CurrentUser - display name of the current user.

 

Help Link

Just like the web site, the following help link (with this 'question mark' image) can be included in an E-Doc to take users to the E-Docs Help page in this help system.

The url is https://www.hrectrack.com.au/help/?id=HRECTrack_EDocsHelp.

 

 

 HREA

The HREA application is actually a zip file containing a number of documents and other information.

It is controlled and generated by the NHMRC, and you can find more details here HREA.

Once completed, it is down-loadable by Researchers as a zip (compressed) file.

Inside each HREA zip file is :-

•PDF of the application,

•DOCX (MS Word) of the application,

•RTF of the application,

•XML file of all the fields etc for the application,

•All other attachments uploaded / included in the application.

 

HRECTrack maps the following HREA questions / fields :-

 

HRECTrack attaches the following documents :-

 

Please see the 'Dashboard - EDM' page for details regarding importing.

 

 

 Documents

The document is mentioned first here because it is the default type if no other hrecDocType can be determined.

It requires the "hrecCode=?" and "hrecDocType=Document" meta-data tags to be set.

Optionally, then hrecDocTypeId meta-data tag can also be set (as per details below) to identify the type of document.

Ideally, the "hrecProjectid=?" meta-tag would also be set, but the ProjectId can be derived from the ProjectCode field.

Additionally, the following form fields can be defined :-

* denotes mandatory field.

n.b. If 'exported' from HRECTrack, the document has its internal hrecProjectId stamped, as well as having the ProjectCode field populated. Optionally, if a document field called 'Title' exists, it will also be populated with the project title.

 

Valid values for the hrecDocTypeId meta-data tag are :-

•0 - Other (default if none specified)

•2 - Application Cover Sheet

•4 - Plain Language Statement

•5 - Letter Of Support

•6 - Budget

•7 - Protocol

•8 - Protocol Amendment

•9 - Protocol Supplementary

•10 - Drug Document

•11 - Device Document

•12 - CTN Forms

•13 - CV

•14 - Indemnity

•15 - Patient Information and Consent (PIC) Form

•16 - PIC supplementary

•17 - Pregnant partner release form

•18 - HREC approvals at other sites

•19 - Advertisement/s

•20 - Investigator Drug Brochure

•21 - Diary Cards

•22 - Project Summary

•23 - Newsletters To Participants

•24 - Notices

•25 - Letters

•26 - Protocol Deviation

•27 - File Notes

•28 - Addendums

•29 - Permission To Contact Form

•30 - Data Collection Form

•31 - Protocol Violations

•32 - Administrative Changes

•34 - Clinical Trial Research Agreement

•35 - Patient Declaration Of Continued Study

•37 - Memo

•38 - Insurance

•40 - Tools

•42 - Questionnaire

•43 - Site Specific Assessment

•44 - Change In Personnel Form

•45 - Research Checklist

•47 - Radiation Safety Report

•48 - Site Authorisation Checklist

•49 - HREC Sub-Committee Checklist

•50 - Consent Form

•52 - Memorandum of Understanding

•53 - Publication

•54 - HREA Application Appendix

•55 - HRECMember Review

•?

 

 

 Researcher Application Form

The researcher document requires the "hrecCode=?" and "hrecDocType=Researcher" meta-data tags to be set.

Note that Researchers are uniquely defined based on their email address. Where an email address is found against multiple existing researchers, uniqueness checks are extended to include the surname (last name) field as well. If an existing researcher is found, NO changes are made, and the import is ignored!

Additionally, the following form fields can be defined :-

* denotes mandatory field.

# denotes a mandatory field within a field group or block (in essence, if ANY field in the group is entered by a researcher, then the # fields become mandatory, otherwise the group as a whole is optional).

 

 

Project Application Form

The project application form document requires the "hrecCode=?" and "hrecDocType=Project" meta-data tags to be set.

Additionally, the following form fields can be defined :-

* denotes mandatory field.

# denotes a mandatory field within a field group or block (in essence, if ANY field in the group is entered by a researcher, then the # fields become mandatory, otherwise the group as a whole is optional).

 

 

 Progress Report

The progress report document requires the "hrecCode=?" and "hrecDocType=ProgressReport" meta-data tags to be set.

Ideally, the "hrecProjectid=?" meta-tag would also be set, but the ProjectId can be derived from the ProjectCode field.

Additionally, the following form fields can be defined :-

* denotes mandatory field.

n.b. If 'exported' from HRECTrack, the document has its internal hrecProjectId stamped, as well as having the ProjectCode field populated. Optionally, if a document field called 'Title' exists, it will also be populated with the project title.

 

 

 Amendments

The amendment document requires the "hrecCode=?" and "hrecDocType=Amendment" meta-data tags to be set.

Ideally, the "hrecProjectid=?" meta-tag would also be set, but the ProjectId can be derived from the ProjectCode field.

Additionally, the following form fields can be defined :-

* denotes mandatory field.

n.b. If 'exported' from HRECTrack, the document has its internal hrecProjectId stamped, as well as having the ProjectCode field populated. Optionally, if a document field called 'Title' exists, it will also be populated with the project title.

 

 

 Severe Adverse Events

The severe adverse event document requires the "hrecCode=?" and "hrecDocType=SAE" meta-data tags to be set.

Ideally, the "hrecProjectid=?" meta-tag would also be set, but the ProjectId can be derived from the ProjectCode field.

Additionally, the following form fields can be defined :-

* denotes mandatory field.

n.b. If 'exported' from HRECTrack, the document has its internal hrecProjectId stamped, as well as having the ProjectCode field populated. Optionally, if a document field called 'Title' exists, it will also be populated with the project title.

 

 

 HRECMember Review

The HRECMember Review document requires the "hrecCode=?" and "hrecDocType=HMReview" meta-data tags to be set.

Ideally, the "hrecProjectid=?" meta-tag would also be set, but the ProjectId can be derived from the ProjectCode field.

Additionally, the following form fields can be defined :-

* denotes mandatory field.

n.b. If 'exported' from HRECTrack, the document has its internal hrecProjectId stamped, as well as having the ProjectCode field populated. Optionally, if a document field called 'Title', 'ProjectPI' or 'CurrentUser' exists, they will also be populated with the project title.