Clinical data coordinator

From the data management perspective, the clinical data coordinator (CDC) is the central team member receiving and distributing data-related information to the project team members. The CDC meets with the project team members to review the project material collected and to elicit the rules and special requirements from the statistician, clinician, safety officer, medical writer and regulatory associates. These project materials, rules and special requirements will be considered in conjunction with data management requirements to develop the data management plan. The CDC should prepare the following documents before the clinical trials are initiated ... 

Clinical Data coordinator cc Project team members... 

From the data management perspective, the clinical data coordinator (CDC) is the central team member receiving and to distributing data-related information to the project team members. The CDC meets with the project team members to review the project material collected and to elicit... 

Speas C, Rushing S, Backfield M. Web based data entry in a hormone replacement therapy clinical trial for a data coordinating center. Controlled Clin Trials 2000 20 2S-91S. 

Clinical research coordinators (CRCs) are the research personnel who assist with pahent visits, and perform study-related procedures that do not require a physician (phlebotomy, vital signs, adverse event, and concomitant medicahon discussions, etc.). CRCs provide the PI or physician with data required for interpretation, medical decisions (inclusion/exclusion, dosage adjustment, patient withdrawal, adverse event causality, etc.), and trial oversight. In addition, CRCs are usually responsible for transcribing source documentation (medical records, clinic notes, laboratory reports, etc.) into case report forms (CRF) supplied by the study sponsor. 

In the case of the United States, and its position on biosimilar molecules, one must turn attention to the Dmg Substances Coordinating Committee (DSCC), which deals directly with the Center for Drug Evaluation and Research (CDER). The combined task has been to provide guidance, with CDER indicating that generic companies will need to provide sufficient characterization of their product to show both chemical and biological comparability with previously Ucensed biophar-maceutical, as well as sufficient clinical data to assure the safety and efficacy of their product (see Part Vll, Chapter 4). 

In clinical trials that solely or partially rely on paper forms and pure paper-based data collection systems, participating sites use a mail carrier to send batches of hard copies of completed forms to the coordinating center. With this approach to data, forms and computer programs are necessary to keep track of received batches of completed forms. 

After the data collection phase of a clinical trial is completed and its collected data are analyzed, collected data are archived centrally, usually at the coordinating center, for future reference. The data archive method depends on the data collection system. In paper-based data collection system, the physical paper forms may need to be archived for a specified period of time. Scanning... 

The filing of a full IND, with a formal coordinated writeup of all the supporting data, while necessary 40 years ago, is now an unnecessary requirement in the early-stage clinical programs of most large pharmas and CROs that do this work today. It is a barrier to the easy access to human studies that is needed for proof-of-concept studies (Phases 1 and 2a). There has been very little trouble in the past 20 years with early INDs filed by responsible individuals, corporations and institutions. The system can now be safety adjusted to recognise this fact, by scaling back the IND requirements for responsible entities, based on what has been learned in the past 40 years. 

There are currently five clinical evaluation units within DSEB, each headed by a senior medical officer and supported by pharmacists. Applications are distributed among the five evaluation units based on the therapeutic area of the drug under evaluation. The DSEB contracts a number of external clinical evaluators who are specialist medical practitioners in the medical condition that the proposed new drug is intended to treat. External evaluators may also be contracted to evaluate the Module 4 data. The head of the clinical evaluation unit coordinates the evaluation and makes the final decision on marketing approval as a delegate under the Therapeutic Goods Act. 

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