13.3 Submissions, Authorisation Status and Trial Reporting

Submissions, Authorisation Status and Trial Reporting

The Regulatory Requirements domain covers communication with IRBs/IECs and authorities, protocol amendments and reporting such as safety and clinical study reports. ACRP explicitly limits its examination references to the listed ICH guidelines and Declaration of Helsinki. Learn how a CRA verifies appropriate authorisation and reporting without turning country-specific applications, form boxes or portal timelines into universal exam rules.

Before relevant trial activities begin, the responsible party makes the required submissions or notifications and obtains the necessary approval or authorisation under the applicable framework. Responsibilities differ by region: E6(R3) notes that sponsor or investigator/institution may make submissions, and ethics and authority processes may be combined. The monitoring task is to establish who is responsible and what evidence demonstrates that the activity is permitted.

Submission, receipt and approval are different states

A submission receipt confirms delivery; it does not necessarily establish acceptance, a favourable ethics opinion or authority permission. A request for changes can leave conditions outstanding. A final approval can be limited to a particular protocol version, site, population or activity. Read the decision and its conditions rather than treating any letter from a regulator as a green light.

A tracker should distinguish these states, identify the responsible person and link to actual evidence. It should not replace the underlying decision. A spreadsheet saying approved can be wrong; the source letter may cover an older consent version or contain an unresolved condition.

The submitted package and the site reality

Relevant scientific and operational information can include the protocol, product information, participant materials, qualifications and other documentation required by the reviewing body. The content depends on the activity and framework. The CRA verifies the correct trial, investigator/site, document identities and versions and follows up discrepancies through the authorised sponsor/site process.

Suppose a protocol amendment was submitted globally, but one site's local ethics decision is pending. The global submission does not by itself authorise the site to implement new research procedures. Confirm the required local status and approved transition plan. If an urgent change is needed to eliminate an immediate hazard, protect participants and promptly document/communicate the action rather than waiting for routine administrative processing.

Reporting during the trial

Safety information, changes affecting risk or conduct, relevant noncompliance and trial status can require communication. Use the applicable reporting framework and trial plan for responsibility, recipient, content and timing. Distinguish investigator-to-sponsor immediate SAE reporting from sponsor expedited authority reporting under E2A and from IRB/IEC communication. One route does not automatically satisfy every other obligation.

Maintain the relevant awareness and transmission dates, acknowledgement, questions and follow-up. A sent email without evidence that it reached the designated safety route may be inadequate. Conversely, an automatically generated receipt is not proof that every clinical issue was evaluated. Trace the process to the decision and action required, not merely a message count.

Suspension and resumption

An authority or ethics restriction may apply to a cohort, procedure, recruitment or the whole trial. Establish its scope accurately. Involve the investigator for care of existing participants, the sponsor for wider actions and responsible functions for required notifications. Do not assume that every suspension means abruptly stopping all care, or that a sponsor email can override an authority restriction.

For resumption, verify the actual clearance and conditions, updated documents, relevant training and operational readiness. Preserve the record of what occurred during the restricted period. Backdating a new permission cannot authorise historical activity, and a note to file cannot remove a prior unauthorised exposure.

Completion and results

At completion or termination, the investigator provides relevant summaries/reports under the applicable process; the sponsor prepares trial reports and required communications. E6(R3) supports transparent reporting and informing participants about results and treatment when appropriate and available, respecting their preferences. The Declaration of Helsinki also addresses registration and making research results public, including negative and inconclusive findings.

A CRA contributes accurate site status, participant disposition, resolved or explained data issues and retrievable essential records. They should not infer that marketing approval automatically follows a completed trial, or that a clinical study report proves every record is complete. Reporting is the accountable presentation of the evidence, including meaningful limitations, deviations and quality issues.

Official sources

Checked October 18, 2026: ICH E6(R3), Principles and Annex 1, ICH E8(R1), ACRP CCRA Exam Content Outline.