The Electronic Data Submission Planning Template

(For Submission of Data to FDA)

  1. The first point of contact with the FDA regarding electronic submission of data is the reviewing division for questions about content or structure. Technical questions for CDER can be addressed directly to Office of Business Process Support (OBPS).
  2. For submissions to CDER, each Sponsor should request an OBPS Regulatory Review Specialist to attend the pre-NDA meeting.
  3. TheElectronicData Submission Planning Template should be used by the Sponsor to create the Plan for Electronic Submission of Data to FDA. This Plan is then included with the briefing document sent to the FDA prior to the pre-NDA/BLA meeting. The Electronic Data Submission Planning Template provides a description of the information that should be submitted.
  4. At the pre-NDA/BLA meeting, any changes to the Plan are discussed and noted.
  5. If the Plan is revised at any time including at the pre-NDA/BLA meeting, it should be submitted to the IND with a copy to OBPS for CDER. This language may be expanded to include other Centers as they adopt SDTM more broadly.
  1. General Submission Information

  1. Planned submission date:

  1. Company name and address:

  1. Contact Name:

  1. Contact Name phone number:

  1. Contact Name email address:

  1. Contact Name mailing address:

  1. IND number:

  1. NDA number:

  1. Name of therapy/compound:

j.Description of the Project:

k.List of the applicable Guidance:

l.General folder structure:

m.Specify format of submission files:

n. Method of delivery to FDA:

2. Information Pertaining to Submitted CRFs

This section should include information on how Case Report Forms are submitted as required by 21 CFR 314.50(f)(2).

3. Information Pertaining to Submitted Clinical Datasets and Metadata

  1. Datasets

Describe in this section what type of datasets will be submitted for each trial.

Data Submission Planning Template v2 2007-10-16.doc; Page 1 of 7

The Electronic Data Submission Planning Template

(For Submission of Data to FDA)

Table 3.a.1

Datasets for Major Indication:
Category/
Protocol / Data Tabulation Dataset (SDTMIG* (version #) / Analysis Datasets / PK Datasets / Comments**

*Include the CDISC Study Data Tabulation Model Implementation Guide (SDTMIG) version number with check

mark.

**Include notes about data cut-off dates if appropriate.

Table 3.a.2

Other Relevant Datasets (if appropriate)
Category/
Protocol /
Indication
/ Data Tabulation Dataset (SDTMIG* (version # / Analysis Datasets / PK Datasets / Comments*

*Include reason for including dataset and also include notes about data cut-off dates if appropriate.

Table 3.a.3

Datasets for Integrated Summary
Category/
Protocol / Pooled Safety Analysis for XXX* / Pooled Efficacy Analysis for YYY* / Pooled ZZ* Analysis for WWW* /
Comments

Data Submission Planning Template v2 2007-10-16.doc; Page 1 of 7

The Electronic Data Submission Planning Template

(For Submission of Data to FDA)

* Column headings should reflect pooled databases used to conduct integrated analyses.

b.Metadata

  • Define.pdf/xml
  • Annotated CRFs

c.Integration

Describe how the integrated datasets will differ from the individual protocol datasets. Please cover these areas:

1)Dictionary coding

2)Treatments

3)Visits

4)Changes to variable names, formats, labels

Data Submission Planning Template v2 2007-10-16.doc; Page 1 of 7

Example of Completed Electronic Data Submission Planning Template

(For Submission of Data to FDA)

Data Submission Planning Template v2 2007-10-16.doc; Page 1 of 7

Example of Completed Electronic Data Submission Planning Template

(For Submission of Data to FDA)

  1. General Submission Information

  1. Planned submission date:
/ March, 20th 2012
  1. Company name and address:

XYZ Pharma
100 Main Street, Building F
CapitalCity
North Dakota 99999-9999
  1. Contact Name:

  1. Contact Name phone number:

  1. Contact Name email address:

  1. Contact Name mailing address:

XYZ Pharma
100 Main Street, Building F
CapitalCity
North Dakota 99999-9999
  1. IND number:

  1. NDA number:

  1. Name of therapy/compound:

j.Description of the Project:

k.List of the applicable Guidance:

eCTD Guidance; Study Data Specifications, Version 1.3.

l.General folder structure:

m.Specify format of submission files:

n. Method of delivery to FDA: / CDs (Compact Discs)

2. Information Pertaining to Submitted CRFs

This section should include information on how Case Report Forms are submitted as required by 21 CFR 314.50(f)(2).

Studies 002, 003, 005,007,008, 123, 456, 678 are EDC studies and a waiver is requested from submitting any CRFs. Study 376 is paper CRFs and a table of contents is provided as a PDF file named Study376_crftoc.pdf and placed in the CRF folder. Since study 376 is ongoing, CRFs will be provided up until the specified data cut-off date of June 7, 2007. Two (2) patient/subjects died during study 123 and one (1) patient/subject discontinued due to an AdverseEvent (AE) for study 456. CRFS are included for these three (3)patients/subjects.)

3. Information Pertaining to Submitted Clinical Datasets and Metadata

  1. Datasets

Describe in this section what type of datasets will be submitted for each trial.

Table 3.a.1

Datasets for Major Indication:
Category/
Protocol / Data Tabulation Dataset (SDTMIG* (version #) / Analysis Datasets / PK Datasets / Comments**
6 mo Placebo/ Active Controlled
005 /  (3.1) / 
007 /  (3.1.1) / 
008 /  (3.1.1) / 
Dose Ranging
002 /  (3.1.1) /  / PK and Safety only
003
Healthy Subjects
456 / 
123 /  (3.1.1)
678 /  (3.1.1)
376 /  (3.1.1)

*Include the CDISC Study Data Tabulation Model Implementation Guide (SDTMIG) version number with check mark.

**Include notes about data cut-off dates if appropriate.

Table 3.a.2
Other Relevant Datasets (if appropriate)
Category/
Protocol /
Indication
/ Data Tabulation Dataset (SDTMIG* (version # / Analysis Datasets / PK Datasets / Comments*
3-12 mo Placebo/ Active Controlled
021 / Depression /  (3.1) /  / Additional Safety data
075 / Depression /  (3.1.1) /  / Safety data only juxtaposed in the integrated summary of safety

*Include reason for including dataset and also include notes about data cut-off dates if appropriate.

Table 3.a.3

Datasets for Integrated Summary
Category/
Protocol / Pooled Safety Analysis for AEs and Labs / Pooled Safety Analysis for ECG / Pooled Efficacy Analysis for Depression /
Comments
6 mo Placebo/ Active Controlled
005, 007, 008 /  / 
Dose Ranging
002, 003, 004 /  / 

* Column headings should reflect pooled databases used to conduct integrated analyses.

b. Metadata

  • Define.pdf/xml

Each folder will include detailed documentation in the format of the define.xml.
  • Annotated CRFs

Documentation for SDTM datasets will also include a blankcrf.pdf containing annotated CRFs (SDTM).

c.Integration

The pooled safety dataset used Version 14.1 of MedDRA. The pooled dataset includes: 1) verbatim term, 2) preferred term and system organ class from original clinical study report, and 3) preferred term and system organ class from pooled safety analysis.)

REFERENCES

  1. eCTD Specification V 3.2 February 04, 2004

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