Clinical Trial Regulatory Submissions and Approvals
This dataset provides comprehensive records of regulatory submissions and approvals for clinical trials, including IND/NDA applications, protocol amendments, safety reports, annual reports, and related FDA correspondence. It enables robust tracking of compliance activities, approval milestones, and communication with regulatory authorities, making it invaluable for regulatory affairs, clinical operations, and audit readiness.
Sample rows
preview · 8 of 400 rows · all 21 columns| submission_idstring | submission_typestring | safety_reportedboolean | correspondence_typestring | trial_idstring | submission_datedate | regulatory_authoritystring | statusstring | approval_datedate | approval_milestonestring | correspondence_idstring | correspondence_datedate | sponsor_namestring | contact_personstring | contact_emailstring | contact_phonestring | protocol_amendment_numberstring | submission_titlestring | correspondence_summarystring | document_referencestring | notesstring |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SUBM-0001 | IND | false | Information Request | TRIAL-101A | 2021-05-12 | FDA | Under Review | blank | blank | CORR-0001 | 2021-05-25 | Synthelia Biotech | Dr. Emily Carson | emily.carson@ | +1-908-555-1427 | blank | Initial IND submission for phase I oncology trial | FDA requested additional preclinical safety data and clarification on dosing schedule. | s3://synthelia/documents/ind101A.pdf | Submitted according to standard IND process. Awaiting FDA feedback. |
| SUBM-0002 | Protocol Amendment | false | Clarification | TRIAL-101A | 2021-07-08 | FDA | Approved | 2021-07-15 | Protocol Amendment #1 Approved | CORR-0002 | 2021-07-10 | Synthelia Biotech | Dr. Emily Carson | emily.carson@ | +1-908-555-1427 | 1 | Protocol Amendment #1: Inclusion criteria update | FDA requested rationale for broadening inclusion criteria to younger age group. | s3://synthelia/protocols/amendment1.pdf | Amendment approved. Enrollment expanded. |
| SUBM-0003 | Safety Report | true | Information Request | TRIAL-101A | 2022-01-14 | FDA | Submitted | blank | blank | CORR-0003 | 2022-01-21 | Synthelia Biotech | Dr. Emily Carson | emily.carson@ | +1-908-555-1427 | blank | SAE report: Serious adverse event (neutropenia) | FDA requested additional details regarding patient history and outcomes. | https://synthelia.com/safety_reports/neutropenia_2022.pdf | SAE reported within required timeframe. |
| SUBM-0004 | NDA | false | Information Request | TRIAL-202B | 2023-03-05 | FDA | Under Review | blank | blank | CORR-0004 | 2023-03-18 | Global Trials Ltd. | Michael R. Lee | mlee@ | +1-646-555-9843 | blank | NDA submission for SYB-202B oral suspension | FDA requested further clarification on manufacturing controls. | ftp://globaltrials/NDA202B/submission.zip | NDA submitted for new oral suspension formulation. |
| SUBM-0005 | Annual Report | false | blank | TRIAL-202B | 2023-12-11 | FDA | Submitted | blank | blank | blank | blank | Global Trials Ltd. | Michael R. Lee | mlee@ | +1-646-555-9843 | blank | Annual progress report for SYB-202B clinical trial | blank | s3://globaltrials/annual_reports/2023.pdf | Annual report submitted in accordance with FDA requirements. |
| SUBM-0006 | Protocol Amendment | false | Clarification | TRIAL-303C | 2022-09-02 | EMA | Under Review | blank | blank | CORR-0005 | 2022-09-10 | EuroPharm Innovations | Julia Schmidt | julia.schmidt@ | +49-30-555-7821 | 2 | Protocol Amendment #2: Dose escalation plan | EMA requested justification for proposed dose escalation schedule. | https://europharm.eu/protocols/amendment2.pdf | Dose escalation plan under regulatory review. |
| SUBM-0007 | Safety Report | true | Information Request | TRIAL-303C | 2023-01-27 | EMA | Submitted | blank | blank | CORR-0006 | 2023-02-05 | EuroPharm Innovations | Julia Schmidt | julia.schmidt@ | +49-30-555-7821 | blank | SUSAR report: Unexpected allergic reaction | EMA requested patient demographics and intervention details. | https://europharm.eu/safety_reports/susar2023.pdf | Expedited SUSAR report submitted per EMA guidelines. |
| SUBM-0008 | NDA | false | Rejection Letter | TRIAL-404D | 2022-07-14 | EMA | Rejected | blank | blank | CORR-0007 | 2022-08-01 | EuroPharm Innovations | Julia Schmidt | julia.schmidt@ | +49-30-555-7821 | blank | NDA submission for EP-404D extended release tablets | Rejection due to insufficient efficacy data in phase III trial. | ftp://europharm/NDA404D/submission.zip | NDA rejected. Sponsor evaluating next steps. |
| SUBM-0009 | Annual Report | false | blank | TRIAL-505E | 2021-12-22 | FDA | Submitted | blank | blank | blank | blank | CardioGenix Labs | Dr. Steven Patel | steven.patel@ | +1-312-555-7782 | blank | Annual report for phase II cardiovascular trial | blank | s3://cardiogenix/annual_reports/phaseII_2021.pdf | Annual report submitted; no major safety signals. |
| SUBM-0010 | Safety Report | true | blank | TRIAL-505E | 2022-06-08 | FDA | Submitted | blank | blank | blank | blank | CardioGenix Labs | Dr. Steven Patel | steven.patel@ | +1-312-555-7782 | blank | SAE report: Hospitalization due to arrhythmia | blank | s3://cardiogenix/safety_reports/arrhythmia2022.pdf | Serious adverse event reported in clinical phase II. |
| SUBM-0011 | Protocol Amendment | false | Approval Letter | TRIAL-606F | 2023-02-11 | MHRA | Approved | 2023-02-25 | MHRA Protocol Amendment #1 Approved | CORR-0008 | 2023-02-18 | MedicaGroup UK | Sarah Winthrop | sarah.winthrop@ | +44-20-555-1942 | 1 | Protocol Amendment #1: Dose reduction for elderly | MHRA approved protocol amendment with dose modifications for elderly patients. | https://medicauk.com/protocols/amendment1.pdf | Amendment focused on geriatric safety. |
| SUBM-0012 | Annual Report | false | blank | TRIAL-606F | 2023-11-30 | MHRA | Submitted | blank | blank | blank | blank | MedicaGroup UK | Sarah Winthrop | sarah.winthrop@ | +44-20-555-1942 | blank | Annual report for UK phase III diabetes trial | blank | https://medicauk.com/annual_reports/2023.pdf | Annual report for ongoing phase III trial. |
| SUBM-0013 | FDA Correspondence | false | Information Request | TRIAL-707G | 2022-12-04 | FDA | Submitted | blank | blank | CORR-0009 | 2022-12-14 | BioQuest Pharmaceuticals | Dr. Paul Kim | paul.kim@ | +1-857-555-2391 | blank | FDA information request: CMC section clarification | FDA sought clarification on Chemistry, Manufacturing, and Controls documentation. | ftp://bioquest/correspondence/CMC2022.pdf | Sponsor responded to FDA request. |
| SUBM-0014 | IND | false | blank | TRIAL-707G | 2020-04-23 | FDA | Approved | 2020-05-15 | IND Activation Granted | blank | blank | BioQuest Pharmaceuticals | Dr. Paul Kim | paul.kim@ | +1-857-555-2391 | blank | IND submission for phase I rare disease trial | blank | s3://bioquest/ind_submissions/rare_2020.pdf | IND approved for rare disease indication. |
| SUBM-0015 | Safety Report | true | blank | TRIAL-808H | 2024-01-18 | PMDA | Submitted | blank | blank | blank | blank | Nippon Clinical Research | Kenji Tanaka | kenji.tanaka@ | +81-3-5557-9841 | blank | SAE report: Unexpected rash in pediatric patient | blank | https://nipponcr.jp/safety_reports/rash2024.pdf | Pediatric SAE reported to PMDA. |
| SUBM-0016 | Protocol Amendment | false | Approval Letter | TRIAL-808H | 2024-02-02 | PMDA | Approved | 2024-02-18 | Protocol Amendment #1 Approved | CORR-0010 | 2024-02-10 | Nippon Clinical Research | Kenji Tanaka | kenji.tanaka@ | +81-3-5557-9841 | 1 | Protocol Amendment #1: Pediatric inclusion extended | PMDA approved extension of pediatric enrollment. | https://nipponcr.jp/protocols/amendment1.pdf | Amendment focused on pediatric safety and efficacy. |
| SUBM-0017 | Annual Report | false | blank | TRIAL-909I | 2023-09-14 | EMA | Submitted | blank | blank | blank | blank | ImmunoTech Europe | Dr. Lars Muller | lars.muller@ | +49-40-555-2947 | blank | Annual report for phase III immunology trial | blank | https://immunotech.eu/annual_reports/2023.pdf | No major safety concerns in annual report. |
| SUBM-0018 | IND | false | blank | TRIAL-909I | 2022-03-10 | FDA | Submitted | blank | blank | blank | blank | ImmunoTech Europe | Dr. Lars Muller | lars.muller@ | +49-40-555-2947 | blank | IND application for phase II immunology trial | blank | ftp://immunotech/ind_submissions/phaseII.pdf | IND application submitted for US expansion. |
| SUBM-0019 | FDA Correspondence | false | Clarification | TRIAL-111J | 2024-03-01 | FDA | Submitted | blank | blank | CORR-0011 | 2024-03-07 | Atlantic Clinical Trials | Jessica Hunt | jessica.hunt@ | +1-212-555-6381 | blank | FDA clarification letter: DMC recommendations | FDA clarified expectations for Data Monitoring Committee recommendations. | s3://atlanticct/fda_correspondence/dmc2024.pdf | FDA correspondence on DMC reporting. |
| SUBM-0020 | Safety Report | true | blank | TRIAL-111J | 2023-08-19 | FDA | Submitted | blank | blank | blank | blank | Atlantic Clinical Trials | Jessica Hunt | jessica.hunt@ | +1-212-555-6381 | blank | SAE report: Unexpected drop in platelet count | blank | https://atlanticct.com/safety_reports/platelet2023.pdf | SAE related to platelet count submitted per FDA timelines. |
What the 400 rows show
from the 400-row sampleSafety Report (submission type) stands out: 79 of its 79 rows have safety_
- 22%safety_
reported = true - 5statuses
- 6regulatory authorities
- 11protocol amendments
- 105contact persons
- 107sponsor names
- string 17
- date 3
- boolean 1
Columns
21 columns in three groups| column | type | description | example |
|---|---|---|---|
| Text 17 columns | |||
submission_id | string | Unique identifier for each regulatory submission recordunique | SUBM-0001 |
trial_id | string | Unique identifier for the clinical trial associated with the submission | TRIAL-101A |
submission_type | string | Type of regulatory submission (e.g., IND, NDA, protocol amendment, safety report, annual report)7 values | IND |
submission_title | string | Title or brief description of the submission document | SAE Update - CNS Trial |
regulatory_authority | string | Name of the regulatory authority receiving the submission (e.g., FDA, EMA)6 authorities | FDA |
status | string | Current status of the submission (e.g., Submitted, Under Review, Approved, Rejected, Withdrawn)Submitted · Under Review · Approved · Rejected · Withdrawn | Under Review |
approval_milestone | string | Milestone achieved upon approval (e.g., IND Activation, NDA Approval)optional | IND Activation Granted |
correspondence_id | string | Unique identifier for related FDA or regulatory correspondenceoptional | CORR-0001 |
correspondence_type | string | Type of correspondence (e.g., Information Request, Clarification, Approval Letter, Rejection Letter)5 values · optional | Information Request |
correspondence_summary | string | Summary or notes from the regulatory correspondenceoptional | FDA requested additional … |
sponsor_name | string | Name of the sponsor organization submitting the application | Synthelia Biotech |
contact_person | string | Primary contact person for the submissionoptional | Dr. Emily Carson |
contact_email | string | Email address of the contact personoptional | mlee@ |
contact_phone | string | Phone number of the contact personoptional | +1-908-555-1427 |
document_reference | string | Reference or link to the submitted documentoptional | s3://synthelia/documents/… |
protocol_amendment_number | string | Number or identifier of the protocol amendment (if applicable)11 amendments · optional | 1 |
notes | string | Additional notes or comments about the submissionoptional | IND activation approved. |
| Dates and times 3 columns | |||
submission_date | date | Date the submission was sent to the regulatory authority | 2021-05-12 |
approval_date | date | Date the submission was approved (if applicable)optional | 2021-07-15 |
correspondence_date | date | Date of correspondence from the regulatory authorityoptional | 2021-05-25 |
| True or false 1 column | |||
safety_reported | boolean | Indicates if a safety issue was reported in this submissionoptional | false |
Use it for
A healthcare dashboard
The safety_
reported rate, safety_ reported by submission_ type and a breakdown of correspondence_ type. Excel, Power BI or Tableau. Why do 83 of 370 rows have safety_
reported = true? A root-cause class exercise
Hand out the rows and one question. The answer is in the data, not in the brief.
- Submissions400SUBM-0001INDSUBM-0003Safety R…SUBM-0007Safety R…
A software demo
Believable submissions with trial_
id, submission_ type and submission_ title to fill a screen in front of a buyer.
This dataset400 rows21 columns
Yours1,000 rows21 columns
blueprint · clinical-trial-regulatory-submissions-and-approvals
Behind this dataset
Same schema. As many rows as you need.
These 400 rows came out of a blueprint — 21 columns with generation rules behind each one. Open it in Data Factory to retune a column, add your own, wire in foreign keys, and run it at the size you actually need.
Rules it was built with
- Submission ID unique per filing
- Submission type: IND, NDA, BLA, amendment, safety report
- IND (Investigational New Drug) number
- NDA (New Drug Application) number
- Protocol version and amendment number
- Submission date to FDA
- FDA action: safe to proceed, clinical hold, approval, complete response
- Clinical hold reason if applicable
Open the blueprint in Data Factory
1 credit per row. Preview 20 rows free. Buy rows for the full run.
- Exports
- CSV, JSON, JSONL, Parquet, SQL, Excel, TSV, XML
- Licence
- yours to use, including commercially
- API slug
- clinical-trial-regulatory-submissions-and-approvals